25944 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

DEPARTMENT OF HEALTH AND Due to staffing and resource withdrawn by procedures such as HUMAN SERVICES limitations, we cannot accept facsimile phlebotomy, or, in the case of blood, (FAX) copies of comments. Nor can we diverted from the circulatory path. The Public Health Service accept comments by telephone. circulatory path is defined as either the FOR FURTHER INFORMATION CONTACT: body’s normal circulatory blood flow or Specific List for Categorization of Rosemary C. Bakes-Martin, (404) 488– a path established by a life-sustaining Laboratory Test Systems, Assays, and 7655. apparatus such as the ‘‘heart-lung’’ Examinations by Complexity machine. To be considered as a normal SUPPLEMENTARY INFORMATION: All circulatory path, the ‘‘heart-lung’’ AGENCY: Public Health Service, HHS. requests for recategorization received machine blood flow must be for the during the 30 day comment period ACTION: Notice with comment period. purpose of sustaining life and not for provided in the July 26, 1993 Federal the purpose of performing testing. The Register notice (59 FR 39860) resulted SUMMARY: Regulations codified at 42 examination of materials removed or in extensive review of available product CFR 493.17, implementing the Clinical diverted from either of these circulatory information and the original complexity Laboratory Improvement Amendments paths (normal or life sustaining) meets scoring for the individual test system, of 1988 (CLIA), Public Law 100–578, the definition of ‘‘in-vitro’’ testing and assay, or examination under require that the Secretary provide for is subject to the CLIA regulations. An consideration. If the requestor submitted the categorization of specific laboratory example of this type of procedure is new information, the test system was test systems, assays, and examinations ‘‘ex-vivo’’ blood gas testing performed by level of complexity. The criteria for rescored taking into account the new on a specimen diverted or removed by such categorizations also are set forth in information. Any changes in means of an indwelling radial catheter. those regulations. categorization or reasons for not making (This indwelling catheter has not been A compiled list of approximately changes are addressed in this Notice established for the purpose of sustaining 12,000 specific clinical laboratory test under the section Comments and life and is outside the circulatory flow.) systems, assays, and examinations Responses. All tests that meet the definition of ‘‘in- categorized by level of complexity was Comments in response to the July 26, vitro’’ testing are subject to CLIA published in the Federal Register on 1993 Notice, that requested additional regulations. ‘‘In-vivo’’ testing, i.e. testing July 26, 1993 (58 FR 39860). This notice laboratory tests be waived of specific that is not removed or diverted from a contains responses to the comments CLIA requirements, were deferred in normal or life sustaining circulatory submitted on those aspects of the July light of the moratorium declared on path, is not subject to CLIA regulation 26, 1993 publication that were subject to classifying testing devices as waived at the present time. An example of this comment. This Notice also announces tests on February 18, 1993. The CDC type of testing is pulse oximetry. Please approximately 2900 additional test lifted the moratorium on waiver on note, however, that we are presently systems, assays, and examinations that December 19, 1994, and has now investigating the definitional and have been categorized since the resumed reviewing requests for waiver technical issues, and necessary publication of the compiled test list. status. On the date that the moratorium revisions to the regulations that would Included in this list of additional was lifted, a letter was sent to make ‘‘in-vivo’’ testing subject to CLIA. categorizations are those test systems manufacturers of laboratory testing Should it be determined at a later date which received 510(k) or premarket devices, that included guidelines that that it is subject to CLIA, proper notice approval from the Food and Drug manufacturers may use to submit their and opportunity for public comment Administration (FDA) during the period requests for waiver. Requests for waiver will be provided before this testing is from September 1, 1992 to March 15, will be evaluated in the order in which subject to CLIA regulation. 1995. Also included are additional test they are received. The context in which the test results systems that were cleared prior to that The public has requested that test are being evaluated, i.e. monitoring period and noted by commenters as categorization information be made versus measurement, is not a missing from the compiled test list. available electronically. CDC is consideration for test complexity. providing computer access to this Comment: A few manufacturers DATES: Effective date: The information via the Internet. For further commented that some of their test categorizations on this list were information regarding this capability, systems should not be categorized for effective on the date of the test please call (404) 488–7655. certain analytes because the company categorization notification letter sent to did not supply the reagents for Comments and Responses the manufacturer. Written comments on performing these tests on the the tests initially categorized in this Comment: A manufacturer requested instruments listed. Notice will be considered if they are clarification of what determines Response: Although the company received at the address indicated below, whether a testing device is subject to which manufactures a test system may by no later than 5 p.m. on June 14, 1995. CLIA regulations. The commenter had not have developed an assay procedure CDC reserves the right to reevaluate and concerns about measuring versus for a particular analyte, it is quite recategorize tests based on the monitoring devices and ‘‘in-vitro’’ possible that another company could comments received in response to this versus ‘‘in-vivo’’ testing. design an assay procedure that has been Notice. Response: All clinical laboratory tests cleared by the FDA for use on the test ADDRESSES: Comments on the performed on materials derived from the system. In such a situation, the analyte categorization of tests initially human body for the purpose of will be listed as being available on the categorized in this Notice should be providing information for the diagnosis, test system. If the assay developed by addressed to Public Health Service, prevention, or treatment of any disease, the reagent manufacturer does not Attention: CLIA Federal Register Notice, or the assessment of the health of, perform as it should on the test system, Centers for Disease Control and human beings are subject to CLIA it is the responsibility of the laboratory Prevention, Mail Stop F–11, 4770 regulations. The term ‘‘derived from the performing the testing or the Buford Highway, NE., Atlanta, Georgia human body’’ refers to any specimen manufacturer of the test system to 30341–3724. that is expelled from the human body, inform the FDA. Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25945

Comment: Abbott Laboratories Response: In response to the enumerate the cellular elements under commented that the compiled list continuing concerns regarding the evaluation, generally scored as moderate published on July 26, 1993 in the categorization of HDL cholesterol, CDC complexity. Federal Register did not specifically once again reassessed the assigned Comment: One manufacturer state whether the analytes Toxoplasma scores for HDL as performed by requested recategorization of some gondii Antibodies, Cytomegalovirus automated methods. The original CLIAC alpha-fetoprotein procedures from high Antibodies, and Rubella Antibodies on discussion had focused on the question complexity to moderate complexity. the Abbott IMX were for determining of the training and experience, and Response: Material serum alpha- IgG, IgM, or total antibodies. interpretation and judgment necessary fetoprotein (AFP) procedures require Response: The analyte nomenclature for the analyst to make appropriate extensive training, interpretation and for antibodies to cytomegalovirus, decisions (e.g., evaluation of the judgment. The analyst must use patient toxoplasmosis, and rubella does not supernatant’s turbidity in the information related to the weeks of specify that the antibodies are total, IgG, pretreatment precipitation step) during gestation in conjunction with the or IgM antibodies. In those instances the testing process. It was on this issue procedure value to obtain a reportable where a kit is used to identify the that CDC determined that analyst result. Amniotic fluid specimens for antibodies, the test system name will interaction was of a lesser degree for AFP may require preanalytic testing to frequently specify that the antibodies some automated methods than for determine the presence of interfering being detected are either total others. Therefore, following the CLIAC substances which can lead to result antibodies, or IgG or IgM specific recommendation for reevaluation of misinterpretation or they may need antibodies. When the test system name these score assignments, some HDL manipulation of the sample to produce does not include the specific antibody, procedures were recategorized from a clear supernatant. Extensive as is the case with the automated high to moderate complexity. In interpretive and judgment skills are also analyzers, then the generic response to the comments on the July necessary to resolve technical problems, nomenclature for the antibody can refer 26, 1993 test list that announced this such as improper specimen collection, to total or specific antibodies. We do not group of recategorizations, we have or determine the need for repeat testing. see this nomenclature as a problem reevaluated all HDL procedures for All of these considerations are in because the test complexity for the consistency in applying the criteria addition to those related to the procedure will be the same regardless of ‘‘Reagents and Materials Preparation’’. methodology of the testing procedure. whether the antibodies being detected Under this criteria, a score of ‘‘1’’ is At the present time, all procedures for are total are specific antibodies. assigned when the manufacturer maternal serum AFP and amniotic fluid Comment: One organization, after provides that analyst with an automated AFP score in the high complexity learning of the recommendation by the method of adding quantitative amounts category. Clinical Laboratory Improvement of precipitating reagent to the sample so Comment: On professional Advisory Committee (CLIAC) and that analyst intervention is minimal, or organization voiced support for the high subsequent move of some HDL when the manufacturer provides the complexity scores given to any test that procedures from high to moderate analyst with a dedicated tube containing involves the interpretation of cultures complexity, requested recategorization a single precipitating reagent. As a and requires multiple steps for the of HDL procedures back to high result of reevaluating the application of achievement of accurate results. This complexity. The organization felt that this criteria, the following HDL organization suggested that other tests all HDL procedures should receive a procedures have been recategorized now categorized as moderate complexity score of ‘‘3’’ for the criteria from high complexity to moderate complexity should be categorized as ‘‘Training and Experience’’ and complexity: Abbott TDX, Abbott TDX high complexity for the same reasons. ‘‘Calibration, Quality Control or FLX, Abbott Vision Non Whole Blood The example given was the direct Proficiency Testing Materials.’’ Another HDL Procedure, and the BioAutoMed Coombs test, which the organization manufacturer requested that numerous ASCA. indicated would yield a false negative HDL procedures be recategorized from Comment: One commenter result if the patient read blood cells high complexity to moderate recommended the recategorization of were washed insufficiently. complexity. Other commenters ‘‘large’’ hematology analyzers and Response: We appreciate the indicated that based upon the process microscopy procedures from moderate organization’s statement of support for recategorization of 16 HDL to high complexity. concerning the categorization scores of procedures from high to moderate Response: Using the seven criteria microbiology culture methods. In regard complexity announced in the July 26, established for categorization, to the direct antiglobulin test (DAT), or 1993 Notice, there were some automated hematology analyzers, in direct Coombs, we feel that this assay is inconsistencies in the application of this general, scored as moderate complexity. appropriately categorized as moderate process to other HDL procedures. The Although the large automated complexity since the procedural skills commenters felt that the reagent instruments used in hematology apply are easily acquired, the reagents are preparation requirements for some of multiple principles in their operation, stable and ready to use, and limited the HDL procedures that remained high the instruments do not require extensive knowledge and judgment is required. complexity were not sufficiently analyst intervention or highly The CLIA regulations to do relieve the complicated to warrant a higher score specialized knowledge for operation. laboratory of its responsibility to than those HDL procedures that were Microscopy procedures were also evaluate the competency of its staff or recategorized to moderate complexity. categorized by complexity using the provide sufficient training on The commenters requested that the criteria established for test supervision for the correction of any scores of these HDL procedures be categorization. Those procedures which technical deficiencies. Training on lowered from ‘‘2’’ to ‘‘1’’ in the criterion do not require an extensive level of proper wash techniques to prevent false ‘‘Reagents and Materials Preparation’’ knowledge or training to perform the negative DAT results should be an and that these procedures be evaluation, or do not require an integral part of the training of all recategorized from high complexity to extensive level of judgment or analysts performing these procedures. moderate complexity. interpretive skill to recognize or We do not feel that the degree of 25946 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices decision making, interpretation, and of the test system when the primary high complexity due to the advanced judgment required to perform a DAT media is observed to determine whether level of interpretation, judgment, approaches the level required to isolate growth is present after an incubation knowledge, and experience required to and identify organisms from culture. period. We have previously stated that obtain an accurate result. Comment: Several commenters if a culture is read even to the point of Response: The test systems for expressed confusion concerning the providing a result of ‘‘No growth’’ it is dermatophytes that have been categorization of rapid strep test kits. considered to be an identification from categorized as moderate complexity are Some referred to them as high culture, and, therefore, the laboratory tests performed on selective media that complexity procedures. reporting the result must be certified to detect the presence or absence of Response: Most of the tests that detect perform the entire culture procedure. In dermatophytes, but do not identify these streptococcal antigen directly from a response to the confusion as to whether fungi. These test systems require throat swab are categorized as moderate the determination that there is either significantly less knowledge, complexity tests. They require some growth or no growth on primary culture experience, interpretation, and knowledge, training and judgment to plates, including the final reporting of a judgment than high complexity cultures accurately perform the procedure. They ‘‘No growth’’ culture result, falls into for isolation and complete identification are not categorized as high complexity the moderate or high complexity of fungi, in which organisms must be tests because they do not require the category, we have created a new test transferred and identification level of knowledge, training, experience system designation, (22167) ‘‘Growth/ procedures performed. Based on the and interpretative skill that is required No Growth of Bacteria on Solid Culture information we have received to date, of a high complexity procedure such as Media’’, which is categorized as we believe that the test systems for isolation and identification of an moderate complexity. This test system dermatophytes using selective media are organism from culture. designation applies to a result appropriately categorized as moderate Comment: Several commenters determined after examining a culture complexity. requested that throat and urine cultures, from any body site, that was initially Comment: Several commenters and urine susceptibility testing be inoculated on solid culture agar or requested that the following analytes recategorized from high to moderate media. It does not apply to cultures and test systems be recategorized from complexity. A few other commenters inoculated into a broth medium such as moderate to high complexity: agreed with high complexity heart infusion broth, thioglycollate categorization of microbiology cultures N. gonorrhoeae (from urogenital or medium, or to conventional broth blood rectal only) due to the advanced level of cultures. Final reports for this moderate interpretation, judgment, knowledge, Test system—All presumpt. ID using complexity test system are limited to select, media, oxidase, and gram and experience required to obtain an ‘‘Growth’’, ‘‘Growth—referred for accurate result when performing these stain identification or interpretation’’, or ‘‘No Streptococcus, group A (from throat procedures. growth’’. A result of ‘‘No growth’’ means Response: Isolation, identification, only) that there are NO bacterial colonies on Test system—All presumpt. ID w/ and susceptibility testing of the media after incubation. The microorganisms from culture is a selective media, hemolysis, and presence of ‘‘normal flora’’, bacitracin complex process regardless of the contaminants, or any organism not source of the culture. It requires considered a pathogen could not be Response: These two tests for significant knowledge, training, and interpreted or reported as ‘‘No growth’’. presumptive identification of a single interpretation for the selection and Individual biochemical tests that are microorganism on selective media from performance of the individual test performed as part of the total culture of a specific body site were components in this process, which may identification process (e.g. oxidase, placed in the moderate complexity include staining for microscopic catalase) are not categorized as separate category because the knowledge, evaluation, subculturing, and tests. Those test systems or kits that training, interpretation and judgment performing the appropriate biochemical usually contain a group of biochemical required is significantly less than that analyses. Taking these factors into or serological tests, and result in the needed to distinguish multiple consideration when scoring for definitive identification of a organisms and determine the presence complexity, these test systems are microorganism are categorized. Several of pathogens, normal flora, or appropriately categorized as high selective culture media that do not contamination in a culture initially complexity. require transfer from the initial plate, inoculated on general nonselective Comment: One commenter asked and result in preliminary identification culture media. For these reasons, we whether the use of general microbiology of a specific microorganism, have been disagree with these commenters, and culture media, such as sheep blood agar, categorized as moderate complexity these tests will remain categorized as was categorized. There has also been tests. The degree of training and moderately complex. some confusion as to whether experience, judgment and interpretive Comment: One commenter requested inoculation of primary culture media or skills required to recognize one specific that Gram stain procedures performed the determination of a ‘‘No growth’’ colony type or reaction on these on endocervical specimens be final culture result is considered a high selective media is significantly less than recatogorized from moderate to high complexity test. what is required for selecting specific complexity. Response: Primary inoculation of colonies from the growth on primary Response: Gram stains from urethral microbiology culture media (e.g. blood culture plates, and performing definitive and endocervical smears are categorized agar, chocolate agar, MacConkey agar, identification tests on pure cultures of as moderate complexity procedures, heart infusion broth) is not considered these organisms. while Gram stains from other sources a complete test system under the CLIA Comment: One commenter requested are categorized as high complexity regulations. The process of isolation and that all of the test systems for procedures as determined by the scoring identification from the primary culture dermatophytes that have been criteria established for test is considered a total test system. The categorized and published as moderate categorization. Smears from urethral inoculation of the media becomes part complexity should be recategorized as and endocervical sources do not tend to Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25947 contain the variety of microorganisms or result reading and data reduction. glucose monitoring devices cleared by cell types that can be seen on smears Regardless of the reading system used, the FDA specifically for home use’’ as taken from other sources. Therefore, the the analyst must prepare multiple waived tests. The Ames Glucometers are knowledge, training and experience, reagents prior to testing, some of which glucose monitoring devices that were interpretation and judgment required to require special handling; the process recently cleared by the FDA for home interpret a Gram stained smear from requires manual addition of specimen to use; therefore, they are now listed as urethral or endocervical sources is not the chamber using a syringe, followed waived tests. as extensive as that required to interpret by timed incubation, multiple wash Please note that in this list of gram stain smears from other sources. steps, addition of reagents, a second additions to the CLIA test categorization Although we agree that there is a timed incubation and more wash steps. list, we have included the test systems difference in the interpretation and It is only after these second wash steps (58311) Separation Technology STI judgment required for Gram stained are completed that the CLA–1 HemataStat II and (58309) Separation smears from urethral versus Chemiluminescent Analyzer automates Technology STI HemataStat Model C70 endocervical sources, we do not believe the photodevelopment, result reading under the analyte (9581) Spun that difference is sufficient to place the and data reduction, while the Microhematocrit as waived procedures. Gram stain evaluations performed on Densitometer system requires manual On previous lists of waived procedures, endocervical smears into high photodevelopment, followed by result we did not list individual test systems complexity. This issue was presented to, reading and data reduction on the capable of obtaining results for spun and discussed by, CLIAC. The CLIAC instrument. hematocrit, but rather listed the all- felt that CDC’s assessment of the level We have reviewed the MAST CLA inclusive test system designation of difficulty for performing the Allergy System taking into account both (04420) ‘‘All Spun Microhematocrit evaluations was appropriate, thus the methods of final result determination Procedures’’. The two Separation Gram stain of endocervical smears will and have concluded that due to the Technology test systems have been remain in the moderate complexity knowledge, training and skills necessary listed in response to requests from the category. to perform the IgE assays properly, this public to clarify that these test systems Comment: One commenter requested test system belongs in the high are indeed spun microhematocrit that the MAST CLA–1 Luminometer complexity category. However, for procedures. The all-inclusive test System be recategorized from high to purposes of clarification, we have listed system designation (04420) will moderate complexity. The commenter the system in this Notice in such way continue to be included on the waived noted that this is a different request that the method of result determination list to indicate that, at the present time, from earlier correspondence requesting is clearly specified, and it is now listed all spun microhematocrit test systems that the MAST Allergy Densitometer twice, as follows: (40176) MAST CLA are waived procedures. We do System be recategorized from high to Allergy System (densitometer) and encourage the public to contact us if moderate complexity. (40177) MAST CLA–1 there are questions about whether other Response: We would like to Chemiluminescent Allergy System. Both specific test systems meet this emphasize that we assess the are categorized as high complexity. definition. In the future, we will include complexity of every analyte on each Comment: One commenter requested all test systems by manufacturer’s name individual instrument and do not that the Scandipharm CF INDICATOR on the waived list. categorize instruments by complexity SWEAT TEST SYSTEM (CFIS) be given without analytes. Additionally, the the same status as the physician- Additions entire testing process of preanalytic, performed microscopy procedures so In this publication, we are analytic, and postanalytic steps, that access to cystic fibrosis screening announcing the categorization of two including the process for determination would not be restricted. laboratory procedures that are normally of results, are evaluated for Response: The Scandipharm CF performed in dental offices. The dental categorization. Thus the instrument INDICATOR SWEAT TEST SYSTEM procedures for (4965) Proteolytic used to read the final results is not (CFIS) does not meet the criteria for enzymes are listed in the speciality of graded independently of the total testing physician-performed microscopy General Chemistry, and for (1317) process. The analytes for which the procedures (PPM). The PPM Dental plaque, in bacteriology. MAST CLA Allergy System has been examinations include only specific categorized as a high complexity test microscopic procedures performed on Corrections system are ‘‘allergen specific IgE’’ and specimens that are derived from The following corrections to the list of ‘‘immunoglobulins IgE’’. patients as part of the physical test systems, assays and examinations As in our earlier response regarding examination. We have received published previously in the Federal the MAST CLA Allergy System, we numerous comments suggesting that Register are based on supplemental maintain that high complexity is the another level of complexity be information provided by the appropriate complexity rating for the established that is intermediate between commenters during the comment period MAST CLA Allergy System. While it is waived and moderate complexity. HHS or as a result of corrections of data entry true that there are two different means is taking these suggestions under errors. The CDC should be notified of to measure test results for this advisement. any changes in manufacture or test procedure, i.e., by densitometer or by system names so that these changes can Additions to Waived Category using the MAST Chemiluminescent be included in the next published test Analyzer (CLA–1), these measuring The Ames Glucometer ENCORE QA list. devices do not significantly change the Blood Glucose Meter (04423) and the complexity of the entire testing process. Ames Glucometer QA Blood Glucose Scandipharm CF Indicator (58240): Substantial training and experience are Meter (04422) have been deleted from The Scandipharm CF Indicator required to perform the complete the list of moderate complexity tests and (58240) (Cystic Fibrosis Sweat Test) has procedure. The steps in the procedure have been added to the list of waived been deleted from the high complexity are manually executed and are tests. Section § 493.15(c) of the CLIA category and placed in the moderate performed in the same way except for regulations lists ‘‘blood glucose by complexity category based upon new 25948 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices information supplied by the Analytes, Nonautomated. These entries analytes: (0410) Adenovirus, (2828) manufacturer regarding the sample have been corrected to read Bio-Scan Influenza A, (2829) Influenza B, (4959) collection. Previous information had Bio-Gen in this notice. Parainfluenza 1, (4960) Parainfluenza 2, indicated that the amount of analyst (4961) Parainfluenza 3, and (5503) Access Medical Systems ImmunoClone involvement in the collection of the Respiratory syncytial virus. HCG Test (04377): sample was more extensive than that (0456) Antithrombin III (ATIII): indicated in the new information. Upon An entry under HCG, Serum, evaluation of this information supplied Qualitative, was incorrectly listed as Instrumentation Laboratory IL ACL by the manufacturer, it was determined Access Medical Systems ImmunoClone 100 (28073) has been deleted from the that the training and experience and (direct Ag/visual) (04311) and has been analyte (0456) Antithrombin III (ATIII) interpretation and judgment required by revised to read Access Medical Systems because this analyte is not available on the analyst to successfully perform the ImmunoClone HCG Test (04377). this system. sample collection is not as extensive as bioMerieux Vitek Vidas (07434): (0703) Beta-2 microglobulin: originally indicated. As a result of the adjustment of scores for relevant The test system bioMerieux Vitek Du Pont Medical Products aca II criteria, the Scandipharm CF Indicator Vidas (07434) for the analyte (6111) (13172) has been deleted from the now registers a total score that places it Thyroxine, Free (FT4) has been revised analyte beta-2 microglobulin because in the moderate complexity category. to Vitek Systems Vidas (67038) for this analyte is not available on this consistency in the listing of test system. International Technidyne Corporation: systems, assays, and examinations. (4908) Platelet Count: As noted in the preamble to the Incorrect Test System Codes compiled test list, the analyte heparin The test systems Abbott Cell-Dyn 400 was removed from the International Incorrect test system codes were (04230), Abbott Cell-Dyn 500 (04231), Technidyne Corporation systems inadvertently assigned to several and Abbott Cell-Dyn 700 (04233) have because the relevant analytes were systems on the previous test list and been deleted from the analyte platelet either (2539) heparin dose response have been corrected as follows: count because these instruments do not (HDR) or (2538) heparin/protamine Gen-Probe Legionella Rapid Diag. analyze this analyte. Systems (including culture) was titration (HPT). These systems were Analyte Nomenclature and Use inadvertently omitted in the compiled incorrectly assigned the test system test list for the analytes HDR or HPT. code (22126). The correct code is We will use the term ‘‘direct This error has been corrected in the (22160). bilirubin’’ to refer to the analyte Gen-Probe M. Pneumoniae Rapid database and the systems are listed in ‘‘conjugated bilirubin’’. Diag. Systems (including culture) was this Notice under the appropriate Due to the different nomenclature incorrectly assigned the test system analytes. systems associated with many flow code (22127). The correct code is cytometer analytes, we will list each (2502) HCG, Serum, Quantitative: (22161). analyte by the terminology furnished by The analyte, HCG, Serum, Gull Laboratories RSV-Mab Test the manufacturer. Quantitative, has been clarified as (direct antigen) was incorrectly assigned Thyroid Peroxidase Autoantibodies (2502) HCG, Beta, Serum, Quantitative. the test system code (22128). The (TPO) and Anti-Thyroid Microsomal correct code is (22162). Antibodies (AMA) refer to the same (4945) Protamine Rate Titration (PRT) Seradyn Colorvue—Giardia (direct analyte. To avoid confusion, we will list The analyte (4945) Protamine Rate Ag/visual) was incorrectly assigned the the analyte nomenclature used by the Titration for the International test system code (58100). The correct manufacturer in the package insert for Technidyne Hemochron test systems code is (58296). the test system being categorized. has been corrected to (4945) Protamine Seradyn Colorvue—Cryptosporidium For purposes of clarification, the Response Test (PRT). (direct Ag/visual) was incorrectly analyte (1033) for Cortisol, Urine has assigned the test system code (58101). been modified to read Cortisol, Urine MicroProbe Affirm VP Identification Kit The correct code is (58297). (direct procedure), and a new analyte (40135) for the detection and Deletions (1095) Cortisol, Urine (extraction identification of (2212) Gardnerella procedure) has been established. vaginalis: (4023) Myoglobin: Speciality/Subspeciality Changes Identification of G. vaginalis using the The analyte myoglobin was listed in MicroProbe Affirm VP Identification Kit both the General Chemistry and In previous publications of the Test is categorized as a moderate complexity Immunology speciality areas. It has been Categorization List, analyte/test systems test, and is correctly listed as such on deleted from the Immunology speciality were assigned to speciality/ page 39879 of the July 26, 1993 Federal area. subspeciality categories based upon the Register notice, in the List of Previously most recognized area in the clinical Unpublished Categorizations. The (0444) Anti-Reticulin Antibodies: laboratory where these procedures are erroneous listing of this analyte and test Anti-Reticulin Antibodies on the generally performed. In an effort to system as high complexity in the Scimedx Auto Screen Test System coordinate regulatory responsibilities compiled test list of categorizations has (58016) has been deleted because it has between the Health Care Financing been corrected in this Federal Register not been cleared by FDA for use in the Administration (HCFA) and the CDC, Notice. clinical laboratory. we have redefined the speciality/ subspeciality categories for some Bio-Scan Bio-Gen: (5503) Respiratory viruses (Influenza analytes to conform to HCFA’s common The manufacturer’s name was A&B, parainfluenza): procedure coding system for Medicare inadvertently omitted from several The analyte Respiratory viruses payment. Consequently, in this entries for Bio-Gen test systems, listed (Influenza A&B, parainfluenza) has been publication, you will note that the under (9641) Urine Dipstick or Tablet deleted and replaced with the following analytes (0476) Acetylcholine/choline, Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25949

(0426) Aminoglycosides, (0705) Blood (2533) Human Placental Lactogen (hPL) Difco EZ Streak Urine Culture Device Lead, (1012) Carboxyhemoglobin, (2541) (2812) Insulin (colony court only) (13311) Histamine, and (3712) Lithium have (2818) Insulin-like Growth Factor-1 Savyon Diagnostic DIASLIDE (colony been moved to Toxicology; the analytes (IGF–1) count only) (58290) (0424) Alpha Fetoprotein—tumor (3713) Luteinizing Hormone (LH) Traditional Blood Agar Streak Plate (colony count only) (61131) marker, (1051) C1-Esterase Inhibitor (4025) Metanephrines, Urine Vitek Systems Bac-T-Screen 2000 (C1INH), and (4927) Platelet Antibody— (4934) Parathyroid Hormone—C- (bacteriuria) (67039) detection have been moved to General Terminal Vitek Systems Bac-T-Screen 402A Immunology; the analytes (1049) Cancer (4924) Parathyroid Hormone—Intact (bacteriuria) (67049) Antigen 125 (CA125), (1013) (4925) Parathyroid Hormone—Mid- Vitek Systems Bac-T-Screen 500 Carcinoembryonic Antigen (CEA), molecule (PTH–M) (bacteriuria) (67050) (1015) Ceruloplasmin, (2511) (4914) Progesterone ANALYTE: Chlamydia (1016) Haptoglobin, (3717) Lysozyme, (4911) (4915) Prolactin TEST SYSTEM, ASSAY OR Prealbumin, (4919) Prostatic Specific (5515) Renin EXAMINATION: Antigen (PSA), (4920) Protein Fractions, (5820) Serotonin Abbott TestPack Chlamydia (direct (6114) Transferrin, and (6129) Trypsin (5819) Sex Hormone Binding Globulin antigen/visual) (04518) have been moved to General Chemistry; (6102) Testosterone Wampole Clearview Chlamydia (direct antigen/visual) (70140) the analyte (4021) Malarial Parasite has (6122) Testosterone, Free been moved to Parasitology. Also, a (6110) Thyroid Binding Globulin (TBG) ANALYTE: Clostridium difficile (1022) (6106) Thyroid Stimulating Hormone TEST SYSTEM, ASSAY OR number of analytes that were previously EXAMINATION: listed under the speciality of General (TSH) Meridian Diagnostics ImmunoCard C. Chemistry or the subspeciality of (6107) Thyroid Stimulating Hormone difficile (dir.Ag/visual) (40165) (TSH) (Neonatal) Toxicology are now listed under the ANALYTE: Gardnerella vaginalis (2212) subspeciality of Endocrinology. These (6108) Thyroid Stimulating Hormone— TEST SYSTEM, ASSAY OR analytes, with their respective codes, high sens. (TSH–HS) EXAMINATION: are: (6109) Thyroxine (T4) MicroProbe Affirm VP Microbial (0106) 17 Ketosteroid (6123) Thyroxine (T4), Neonatal Identification Test Kit (40135) (0102) 17 OH Progesterone (6110) Thyroxine Binding Globulin MicroProbe Affirm VPIII Microbial (0103) 17 OH Progesterone, Neonatal (TBG) Identification Test (40163) (0101) 5-Hydroxyindolacetic Acid (5- (6111) Thyroxine, Free (FT4) ANALYTE: Helicobacter pylori (2512) HIAA) (6119) Triiodothyronine (T3) TEST SYSTEM, ASSAY OR (6120) Triiodothyronine Uptake (T3U) EXAMINATION: (0472) Adenosine Monophosphate, Serim PyloriTek Test Kit (58338) Cyclic (cAMP) (TU) ANALYTE: Streptococcus, group A (5810) (0458) Adrenocorticotropic Hormone (6121) Triiodothyronine, Free (FT3) (6710) Vanillylmandelic Acid (VMA) TEST SYSTEM, ASSAY OR (ACTH) EXAMINATION: (0459) Aldosterone Dated: May 2, 1995. Becton Dickinson Precise STREP A (direct (0466) Androstanediol Glucuronide (3 Philip R. Lee, antigen/visual) (07426) alpha-diol G) Assistant Secretary for Health. Syntron QuikPac Strep A (EIA) Test (direct (0460) Androstenedione antigen/visual) (58291) (0479) Angiotensin I List of Previously Unpublished Wampole Clearview Strep A (direct (1040) Calcitonin Categorizations antigen/visual) (70141) (1056) Catecholamines, Plasma The test categorization scoring ANALYTE: Streptococcus, group A (from (1055) Catecholamines, Urine scheme was based on an assessment of throat only) (5828) (1032) Cortisol TEST SYSTEM, ASSAY OR the complexity of the operation of the EXAMINATION: (1033) Cortisol, Urine (direct procedure) test procedure and not on an evaluation Medix Biotech BESTest Strep A (40193) (1095) Cortisol, Urine (extraction of data documenting the procedure’s Quidel QuickVue One-Step Strep A Test procedure) performance over time. Therefore, the (52024) (1043) Cyclic AMP categorization of a test system, assay or ANALYTE: Streptococcus, group B (5811) (1309) Dehydroepiandrosterone (DHEA) examination as moderate or high TEST SYSTEM, ASSAY OR (1310) Dehydroepiandrosterone Sulfate complexity should not be interpreted as EXAMINATION: (DHEA–SO4 an indication of the acceptability or BioStar Strep B OIA (direct antigen/visual) (1611) Erythropoietin unacceptability of the accuracy, (07540) (1605) Estradiol precision or overall performance of the ANALYTE: Vibrio cholerae (6716) (1606) Estriol-Total procedure. TEST SYSTEM, ASSAY OR EXAMINATION: (1607) Estriol-unconjugated COMPLEXITY: MODERATE (1908) Follicle Stimulating Hormone New Horizons CholeraScreen (43084) (FSH) SPECIALITY/SUBSPECIALITY: Bacteriology SPECIALITY/SUBSPECIALITY: (2205) Gastrin ANALYTE: Aerobic &/or Anaerobic Endocrinology (2206) Glucagon Organisms-unlimited sources (0412) ANALYTE: Cortisol (1032) (2502) HCG, Beta, Serum, Quantitative TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR (2501) HCG, Serum, Qualitative EXAMINATION: EXAMINATION: Difco ESP Blood Culturing System (13275) Boehringer Mannheim ES 300 AL (07524) (2555) HCG, Total, Serum, Quantitative Growth/No Growth of Bacteria on Solid (2503) HCG, Urine, Qualitative (non- Boehringer Mannheim Hitachi 914 (07546) Culture Media (22167) Ciba Corning ACS 180 (10046) waived procedures) Organon Teknika Bact/Alert 120 (46148) Cirrus Diagnostics Immulite (10159) (2534) HCG, Urine, Quantitative ANALYTE: Aerobic Organisms from urine Sanofi Pasteur Access Immunoassay (2543) HCG, Whole Blood, Qualitative specimens only (0468) System (58257) (2545) Homovanillic Acid (HVA) TEST SYSTEM, ASSAY OR Schiapparelli Biosystems ACE Clinical (2547) Human Growth Hormone EXAMINATION: Chemistry System (58288) 25950 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

Vitek Systems Vidas (67038) PB Diagnostics Systems OPUS Magnum Boehringer Mannheim ES 300 AL (07524) ANALYTE: Cortisol, Urine (direct procedure) (49097) Du Pont ACA III with aca plus (1033) PB Diagnostics Systems OPUS PLUS Immunoassay System (13253) TEST SYSTEM, ASSAY OR (49098) Du Pont ACA IV with aca plus EXAMINATION: Sanofi Pasteur Access Immunoassay Immunoassay System (13254) Abbott TDX (04071) System (58257) Du Pont ACA Star with aca plus Sanofi Pasteur Access Immunoassay Syva Vista Immunoassay System (58221) Immunoassay System (13358) System (58257) Vitek Systems Vidas (67038) Du Pont ACA V with aca plus Wallac Oy AutoDELFIA (70167) Immunoassay System (13255) ANALYTE: Dehydroepiandrosterone (DHEA) Organon Teknika AuraFlex (46152) (1309) ANALYTE: HCG, Serum, Qualitative (2501) TEST SYSTEM, ASSAY OR PB Diagnostics Systems OPUS Magnum TEST SYSTEM, ASSAY OR (49097) EXAMINATION: EXAMINATION: Abbott TestPack PLUS hCG COMBO PB Diagnostics Systems OPUS PLUS Serono Baker SR 1 (58090) (04375) (49098) ANALYTE: Dehydroepiandrosterone Sulfate Access Medical Systems ImmunoCLONE Roche Cobas Core (55119) (DHEA–SO4) (1310) hCG Test (04377) Sanofi Pasteur Access Immunoassay TEST SYSTEM, ASSAY OR Applied Biotech SureStep Combo hCG System (58257) EXAMINATION: (04528) Syva Vista Immunoassay System (58221) Cirrus Diagnostics Immulite (10159) Disease Detection International Pro-Step Vitek Systems Vidas (67038) ANALYTE: Estradiol (1605) PT hCG (13271) Wallac Oy AutoDELFIA (70167) TEST SYSTEM, ASSAY OR Disease Detection International Pro-Step ANALYTE: Parathyroid Hormone—Intact EXAMINATION: hCG (13270) (4924) Baxter Stratus II (07051) King’s Bay Prelude hCG Combo Kit (34062) TEST SYSTEM, ASSAY OR Baxter Stratus IIntellect (07376) Mainline Technology MAINLINE Confirms EXAMINATION: Boehringer Mannheim ES 300 AL (07524) hCG (40190) Cirrus Diagnostics Immulite (10159) Ciba Corning ACS 180 (10046) Princeton BioMeditech BioSign hCG One ANALYTE: Progesterone (4914) Cirrus Diagnostics Immulite (10159) Step Pregnancy Test (49080) TEST SYSTEM, ASSAY OR PB Diagnostics Systems OPUS (49001) Quidel QuickVue One-Step hCG Combo EXAMINATION: PB Diagnostics Systems OPUS Magnum Test (52022) Baxter Stratus II (07051) (49097) SA Scientific SAS Serum/Urine hCG Baxter Stratus IIntellect (07376) PB Diagnostics Systems OPUS PLUS (58283) Boehringer Mannheim ES 300 AL (07524) (49098) Stanbio QuPid Plus hCG Pregnancy Test Ciba Corning ACS 180 (10046) TOSOH A1A–1200 (61040) (58326) Cirrus Diagnostics Immulite (10159) TOSOH A1A–600 (61039) Syntron Bioresearch QuikPac II hCG TOSOH A1A–1200 (61040) Vitek Systems Vidas (67038) Combo Kit (58353) TOSOH A1A–600 (61039) Wallac Oy AutoDELFIA (70167) TECH–CO Visual HCG Pregnancy Test Wallac Oy AutoDELFIA (70167) (61099) ANALYTE: Estriol-unconjugated (1607) ANALYTE: Prolactin (4915) True Medix Beta Spec hCG (61139) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR Unipath Clearview HCG DUO (64031) EXAMINATION: EXAMINATION: Wallac Oy AutoDELFIA (70167) ANALYTE: HCG, Total, Serum, Quantitative Abbott AxSYM (04532) (2555) ANALYTE: Follicle Stimulating Hormone Boehringer Mannheim ES 300 AL (07524) TEST SYSTEM, ASSAY OR Cirrus Diagnostics Immulite (10159) (FSH) (1908) EXAMINATION: TEST SYSTEM, ASSAY OR Du Pont ACA III with aca plus Ciba Corning ACS 180 (10046) Immunoassay System (13253) EXAMINATION: PB Diagnostics Systems OPUS (49001) Abbott AxSYM (04532) Du Pont ACA IV with aca plus PB Diagnostics Systems OPUS Magnum Immunoassay System (13254) Boehringer Mannheim ES 300 AL (07524) (49097) Du Pont ACA III with aca plus Du Pont ACA SX with aca Immunoassay PB Diagnostics Systems OPUS PLUS System (13313) Immunoassay System (13253) (49098) Du Pont ACA IV with aca plus Du Pont ACA Star with aca plus Immunoassay System (13254) ANALYTE: HCG, Urine, Qualitative (non- Immunoassay System (13358) Du Pont ACA SX with aca plus waived procedures) (2503) Du Pont ACA V with aca plus Immunoassay System (13313) TEST SYSTEM, ASSAY OR Immunoassay System (13255) EXAMINATION: Du Pont ACA Star with aca plus PB Diagnostics Systems OPUS Magnum Applied Biotech Pregslide HCG Test Immunoassay System (13358) (49097) (04498) Du Pont ACA V with aca plus PB Diagnostics Systems OPUS PLUS Diagnostic Specialties Pregna-Cert (13276) Immunoassay System (13255) (49098) J & S Medical Accutex B–HCG Latex Test Organon Teknika AuraFlex (46152) Roche Cobas Core (55119) (31011) PB Diagnostics Systems OPUS Magnum Sanofi Pasteur Access Immunoassay SA Scientific SAS Direct Monoclonal hCG (49097) System (58257) (58319) PB Diagnostics Systems OPUS PLUS Syva Vista Immunoassay System (58221) SA Scientific SAS Monoclonal HCG-Slide (49098) Vitek Systems Vidas (67038) (58281) Roche Cobas Core (55119) Wallac Oy AutoDELFIA (70167) Sanofi Pasteur Access Immunoassay ANALYTE: Human Growth Hormone (GH) ANALYTE: Sex Hormone Binding Globulin System (58257) (2547) (5819) Syva Vista Immunoassay System (58221) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR Vitek Systems Vidas (67038) EXAMINATION: EXAMINATION: Wallac Oy AutoDELFIA (70167) Wallac Oy AutoDELFIA (70167) Cirrus Diagnostics Immulite (10159) ANALYTE: HCG, Beta, Serum, Quantitative ANALYTE: Insulin (2812) ANALYTE: Testosterone (6102) (2502) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR EXAMINATION: EXAMINATION: EXAMINATION: Boehringer Mannheim ES 300 AL (07524) Ciba Corning ACS 180 (10046) Abbott AxSYM (04532) ANALYTE: Luteinizing Hormone (LH) (3713) ANALYTE: Thyroid Stimulating Hormone Boehringer Mannheim ES 300 AL (07524) TEST SYSTEM, ASSAY OR (TSH) (6106) Du Pont ACA Star with aca plus EXAMINATION: TEST SYSTEM, ASSAY OR Immunoassay System (13358) Abbott AxSYM (04532) EXAMINATION: Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25951

Bio-Rad RADIAS System (07493) Bio-Rad RADIAS System (07493) Instrumentation Laboratory ILAB 1800 Cirrus Diagnostics Immulite (10159) Boehringer Mannheim ES 300 AL (07524) (28323) Du Pont ACA Star with aca plus Cirrus Diagnostics Immulite (10159) Instrumentation Laboratory ILAB 900 Immunoassay System (13358) Organon Teknika AuraFlex (46152) (28322) Organon Teknika AuraFlex (46152) PB Diagnostics Systems OPUS (49001) Kodak Ektachem 550 XRC Analyzer PB Diagnostics Systems OPUS Magnum Roche Cobas Core (55119) (34056) (49097) Sanofi Pasteur Access Immunoassay Kodak Ektachem 700 Analyzer C Series PB Diagnostics Systems OPUS PLUS System (58257) (34054) (49098) Technicon Immuno 1 System (61042) Kodak Ektachem 750 XRC Analyzer Roche Cobas Core (55119) Vitek Systems Vidas (67038) (34055) Vitek Systems Vidas (67038) Wallac Oy AutoDELFIA (60167) Kodak Ektachem 950 IRC (34087) Wallac OY AutoDELFIA (70167) ANALYTE: Triiodothyronine (T3) (6119) Kodak Ektachem DT II (34057) ANALYTE: Thyroid Stimulating Hormone TEST SYSTEM, ASSAY OR LSI ASCA Chemistry System (37069) (TSH) (Neonatal) (6107) EXAMINATION: Olympus AU 5041 (46145) TEST SYSTEM, ASSAY OR Abbott AxSYM (04532) Olympus AU 5200 (46143) EXAMINATION: Boehringer Mannheim ES 300 AL (07524) PrismaSystems PROCHEM (49105) Bio-Rad RADIAS System (07493) Organon Teknika AuraFlex (46152) Schiapparelli Biosystems ACE Clinical Chemistry System (58288) ANALYTE: Thyroid Stimulating Hormone— PB Diagnostics Systems OPUS Magnum (49097) Technicon OPERA Clinical Chemistry high sens. (TSH–HS) (6108) System (61161) TEST SYSTEM, ASSAY OR PB Diagnostics Systems OPUS PLUS ANALYTE: Albumin (0414) EXAMINATION: (49098) TEST SYSTEM, ASSAY OR Bio-Rad RADIAS System (07493) Roche Cobas Core (55119) EXAMINATION: Boehringer Mannheim ES 300 AL (07524) Sanofi Pasteur Access Immunoassay Abbott Spectrum CCX (04515) Sanofi Pasteur Access Immunoassay System (58257) Beckman Synchron CX 5 CE (07491) System (58257) TOSOH A1A–120DX (61154) Behring Nephelometer II (07563) Wallac Oy AutoDELFIA (70167) Vitek Systems Vidas (67038) Wallac Oy AutoDELFIA (70167) Boehringer Mannheim Hitachi 914 (07546) ANALYTE: Thyroxine (T4) (6109) Du Pont ACA Star (13357) ANALYTE: Triiodothyronine Uptake (T3U) TEST SYSTEM, ASSAY OR Du Pont Dimension XL (13355) (TU) (6120) EXAMINATION: Instrumentation Laboratory ILAB 1800 TEST SYSTEM, ASSAY OR Abbott AxSYM (04532) (28323) EXAMINATION: Beckman Synchron CX 5 CE (07491) Instrumentation Laboratory ILAB 900 Abbott TDX FLx (04072) Becton Dickinson IQ Immunochemical (28322) Beckman Synchron CX 5 CE (07491) System (07429) Kodak Ektachem 550 XRC Analyzer Becton Dickinson IQ Immunochemical Boehringer Mannheim ES 300 AL (07524) (34056) System (07429) Boehringer Mannheim Hitachi 911 (07377) Kodak Ektachem 700 Analyzer C Series Boehringer Mannheim ES 300 AL (07524) Boehringer Mannheim Hitachi 914 (07546) (34504) Boehringer Mannheim Hitachi 914 (07546) Du Pont ACA Star (13357) Kodak Ektachem 750 XRC Analyzer Du Pont ACA Star (13357) Du Pont Dimension XL (13355) (34055) LSI ASCA Chemistry System (37069) LSI ASCA Chemistry System (37069) Kodak Ektachem 950 IRC (34087) Olympus AU 5041 (46145) Olympus AU 5041 (46145) Kodak Ektachem DT II (34057) Olympus AU 5121 (46087) Olympus AU 5121 (46087) LSI ASCA Chemistry System (37069) Olympus AU 5200 (46143) Olympus AU 5200 (46143) Olympus AU 5041 (46145) Organon Teknika AuraFlex (46152) Organon Teknika AuraFlex (46152) Olympus AU 5200 (46143) PB Diagnostics Systems OPUS Magnum PB Diagnostics Systems OPUS Magnum PrismaSystems PROCHEM (49105) (49097) (49097) Schiapparelli Biosystems ACE Clinical PB Diagnostics Systems OPUS PLUS PB Diagnostics Systems OPUS PLUS Chemistry System (58288) (49098) (49098) Technicon OPERA Clinical Chemistry Sanofi Pasteur Access Immunoassay Roche Cobas Core (55119) System (61161) Sanofi Pasteur Access Immunoassay System (58257) ANALYTE: Albumin, Urinary (0516) System (58257) SPECIALITY/SUBSPECIALITY: General TEST SYSTEM, ASSAY OR Schiapparelli Biosystems ACE Clinical Chemistry EXAMINATION: Chemistry System (58288) ANALYTE: Acid Phosphatase (0407) Du Pont ACA II (13172) Technicon OPERA Clinical Chemistry TEST SYSTEM, ASSAY OR Du Pont ACA III (13173) System (61161) EXAMINATION: Du Pont ACA IV (13083) Vitek Systems Vidas (67038) Du Pont ACA Star (13357) Du Pont ACA Star (13357) Wallac Oy AutoDELFIA (70167) Du Pont Dimension XL (13355) Du Pont ACA V (13084) ANALYTE: Thyroxine Binding Globulin Kodak Ektachem 500 XRC Analyzer ANALYTE: Aldolase (0415) (TBG) (6110) (34056) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR Kodak Ektachem 700 Analyzer C Series EXAMINATION: EXAMINATION: (34054) Boehringer Mannheim Hitachi 914 (07546) Boehringer Mannheim ES 300 AL (07524) Kodak Ektachem 750 XRC Analyzer Technicon Immuno 1 System (61042) ANALYTE: Alkaline Phosphatase (ALP) (34055) (0416) ANALYTE: Thyroxine Uptake (T4U) (TU) Kodak Ektachem 950 IRC (34087) TEST SYSTEM, ASSAY OR (6139) Kodak Ektachem DT II (34057) EXAMINATION: TEST SYSTEM, ASSAY OR LSI ASCA Chemistry System (37069) Abbott Spectrum CCX (04515) EXAMINATION: Olympus AU 5041 (46145) Beckman Synchron CX 5 CE (07491) Du Pont Dimension XL (13355) ANALYTE: Alanine Aminotransferase (ALT) Boehringer Mannheim Hitachi 914 (07546) Schiapparelli Biosystems ACE Clinical (SGPT) (0404) Du Pont ACA Star (13357) Chemistry System (58288) TEST SYSTEM, ASSAY OR Du Pont Dimension XL (13355) Syva Vista Immunoassay System (58221) EXAMINATION: Instrumentation Laboratory ILAB 1800 Vitek Systems Vidas (67038) Abbott Spectrum CCX (04515) (28323) ANALYTE: Thyroxine, Free (FT4) (6111) Beckman Synchron CX 5 CE (07491) Instrumentation Laboratory ILAB 900 TEST SYSTEM, ASSAY OR Boehringer Mannheim Hitachi 914 (07546) (28322) EXAMINATION: Du Pont ACA Star (13357) Kodak Ektachem 550 XRC Analyzer Abbott AxSYM (04532) Du Pont Dimension XL (13355) (34056) 25952 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

Kodak Ektachem 700 Analyzer C Series Boehringer Mannheim Hitachi 704 (07161) PrismaSystems PROCHEM (49105) (34054) Boehringer Mannheim Hitachi 705 (07162) Schiapparelli Biosystems ACE Clinical Kodak Ektachem 750 XRC Analyzer Boehringer Mannheim Hitachi 717 (07163) Chemistry System (58288) (34055) Boehringer Mannheim Hitachi 747 (07166) Technicon OPERA Clinical Chemistry Kodak Ektachem 950 IRC (34087) Boehringer Mannheim Hitachi 911 (07377) System (61161) Kodak Ektachem DT II (34057) ANALYTE: Apolipoprotein A1 (0462) ANALYTE: Bilirubin, Neonatal (0705) LSI ASCA Chemistry System (37069) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR EXAMINATION: Olympus AU 5041 (46145) EXAMINATION: Abbott Spectrum CCX (04515) Olympus AU 5200 (46143) Behring Nephelometer II (07563) Du Pont ACA Star (13357) PrismaSystems PROCHEM (49105) Instrumentation Laboratory IL Monarch Kodak Ektachem 550 XRC Analyzer Schiapparelli Biosystems ACE Clinical 1000 (28082) (34056) Chemistry System (58288) Instrumentation Laboratory IL Monarch Kodak Ektachem 700 Analyzer C Series Synermed IR 500 (58322) 2000 (28231) (34054) Technicon OPERA Clinical Chemistry Instrumentation Laboratory IL Monarch Kodak Ektachem 750 XRC Analyzer System (61161) Plus (28083) (34055) ANALYTE: Alpha-Hydroxybutyrate Olympus AU 5041 (46145) Kodak Ektachem DT II (34057) Dehydrogenase (HBDH) (0419) ANALYTE: Apolipoprotein B (0457) ANALYTE: Bilirubin, Total (0706) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR EXAMINATION: EXAMINATION: EXAMINATION: Beckman Synchron CX 5 CE (07491) Behring Nephelometer II (07563) Abaxis EPOC 2000 (04547) Du Pont ACA Star (13357) Olympus AU 5041 (46145) Abbott Spectrum CCX (04515) ANALYTE: Ammonia, Plasma/Serum (0427) ANALYTE: Aspartate Aminotransferase Beckman Synchron CX 5 CE (07491) TEST SYSTEM, ASSAY OR (AST) (SGOT) (0405) Boehringer Mannheim Hitachi 914 (07546) EXAMINATION: TEST SYSTEM, ASSAY OR Du Pont ACA Star (13357) Abbott Spectrum CCX (04515) EXAMINATION: Du Pont Dimension XL (13355) Abbott VP (04082) Abaxis EPOC 2000 (04547) Instrumentation Laboratory ILAB 1800 Beckman Synchron CX 4 CE (07174) Abbott Spectrum CCX (04515) (28323) Beckman Synchron CX 5 CE (07491) Beckman Synchron CX 5 CE (07491) Instrumentation Laboratory ILAB 900 Beckman Synchron CX 7 (07073) Boehringer Mannheim Hitachi 914 (07546) (28322) Boehringer Mannheim Hitachi 911 (07377) Du Pont ACA Star (13357) Kodak Ektachem 550 XRC Analyzer Boehringer Mannheim Hitachi 914 (07546) Du Pont Dimension XL (13355) (34056) Du Pont ACA Star (13357) Instrumentation Laboratory ILAB 1800 Kodak Ektachem 700 Analyzer C Series Du Pont Dimension XL (13355) (28323) (34054) Kodak Ektachem 550 XRC Analyzer Instrumentation Laboratory ILAB 900 Kodak Ektachem 750 XRC Analyzer (34056) (28322) (34055) Kodak Ektachem 700 Analyzer C Series Kodak Ektachem 550 XRC Analyzer Kodak Ektachem 950 IRC (34087) (34054) (34056) Kodak Ektachem DT II (34057) Kodak Ektachem 750 XRC Analyzer Kodak Ektachem 700 Analyzer C Series LSI ASCA Chemistry System (37069) (34055) (34054) Olympus AU 5041 (46145) Kodak Ektachem 950 IRC (34087) Kodak Ektachem 750 XRC Analyzer Olympus AU 5200 (46143) Kodak Ektachem DT II (34057) (34055) PrismaSystems PROCHEM (49105) ANALYTE: Amylase (0429) Kodak Ektachem 950 IRC (34087) Schiapparelli Biosystems ACE Clinical TEST SYSTEM, ASSAY OR Kodak Ektachem DT II (34057) Chemistry System (58288) EXAMINATION: LSI ASCA Chemistry System (37069) Techicon OPERA Clinical Chemistry Abbott Spectrum CCX (04515) Olympus AU 5041 (46145) System (61161) Beckman Synchron CX 5 CE (07491) Olympus AU 5131 (46088) ANALYTE: Blood Gases with pH (0708) Boehringer Mannheim Hitachi 914 (07546) Olympus AU 5200 (46143) TEST SYSTEM, ASSAY OR Du Pont ACA Star (13357) PrismaSystems PROCHEM (49105) EXAMINATION: Du Pont Dimension XL (13355) Schiapparelli Biosystems ACE Clinical AVL Compact 1 (04552) Instrumentation Laboratory ILAB 1800 Chemistry System (58288) AVL Compact 2 (04555) (28323) Synermed IR 500 (58322) AVL OPTI 1 (04572) Instrumentation Laboratory ILAB 900 Technicon OPERA Clinical Chemistry Ciba Corning 248 (10260) (28322) System (61161) Ciba Corning 840 (10250) Kodak Ektachem 550 XRC Analyzer ANALYTE: Bilirubin, Direct (0704) Ciba Corning 845 (10296) (34056) TEST SYSTEM, ASSAY OR Ciba Corning 850 (10251) Kodak Ektachem 700 Analyzer C Series EXAMINATION: Ciba Corning 855 (10297) (34054) Abbott Spectrum CCS (04515) Ciba Corning 860 (10269) Kodak Ektachem 750 XRC Analyzer Beckman Synchron CX 5 CE (07491) Ciba Corning 865 (10298) (34055) Boehringer Mannheim Hitachi 914 (07546) Diametrics Medical DMI Blood Gas Kodak Ektachem 950 IRC (34087) Du Pont ACA Star (13357) Analyzer (13274) Kodak Ektachem DT II (34057) Du Pont Dimension XL (13355) Diametrics Medical IRMA Blood Analysis LSI ASCA Chemistry System (37069) Instrumentation Laboratory ILAB 1800 System (13362) Olympus AU 5041 (46145) (28323) I-STAT i-STAT 200 System (28344) Olympus AU 5200 (46143) Instrumentation Laboratory ILAB 900 I-STAT i-STAT Portable Clinical Analyzer PrismaSystems PROCHEM (49105) (28322) (28186) Schiapparelli Biosystems ACE Clinical Kodak Ektachem 550 XRC Analyzer Instrumentation Laboratory Blood Gas Chemistry System (58288) (34056) 1610 (28335) Technicon OPERA Clinical Chemistry Kodak Ektachem 700 Analyzer C Series Instrumentation Laboratory Blood Gas System (61161) (34054) 1620 (28336) ANALYTE: Amylase, pancreatic isoenzymes Kodak Ektachem 750 XRC Analyzer Instrumentation Laboratory Blood Gas (p-Amylase) (0500) (34055) 1630 (28337) TEST SYSTEM, ASSAY OR Kodak Ektachem 950 IRC (34087) Instumentation Laboratory Blood Gas 1640 EXAMINATION: LSI ASCA Chemistry System (37069) (28338) Beckman Synchron CX 4 (07071) Olmpus AU 5041 (46145) Instrumentation Laboratory Blood Gas Beckman Synchron CX 5 (07072) Olympus AU 5200 (46143) 1650 (28339) Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25953

Instrumentation Laboratory IL 1430 Technicon OPERA Clinical Chemistry I–STAT i–STAT 200 System (28344) BGElectrolyte (28343) System (61161) Instrumentation Laboratory Blood Gas

Nova Stat profile 7 (43035) ANALYTE: Carbon Dioxide, Total (CO2) 1650 (28339) Nova Stat Profile 9 (43086) (1003) Instrumentation Laboratory IL 1430 Nova Stat Profile Plus 10 (43063) TEST SYSTEM, ASSAY OR BGElectrolyte (28343) Nova Stat Profile Ultra 11P Analyzer EXAMINATION: Instrumentation Laboratory ILAB 1800 (43101) Abbott Spectrum CCX (04515) (28323) PPG Industries StatPal II Blood Gas Beckman Synchron CX 3 Delta (07548) Instrumentation Laboratory ILAB 900 Analysis System (49092) Beckman Synchron CX 5 CE (07491) (28322) Radiometer ABL 5 (55136) Boehringer Mannheim Hitachi 914 (07546) Instrumentation Laboratory ILyte Na, K, C1 Radiometer ABL 620 (55137) Du Pont ACA Star (13357) System (28320) Ionetics Model 400/450 Electrolyte ANALYTE: Blood pH (no blood gases) Du Pont Dimension XL (13355) Analyzer (28324) (07221) Kodak Ektachem 550 XRC Analyzer Kodak Ektachem 550 XRC Analyzer TEST SYSTEM, ASSAY OR (34056) (34056) EXAMINATION: Kodak Ektachem 700 Analyzer C Series (34054) Kodak Ektachem 700 Analyzer C Series AVL 9110 pH Analyzer (04523) (34054) AVL 988–4 (04556) Kodak Ektachem 750 XRC Analyzer (34055) Kodak Ektachem 750 XRC Analyzer Ionetics Model 400/450 Electrolyte (34055) Analyzer (28324) Kodak Ektachem 950 IRC (34087) Kodak Ektachem DT II (34057) Kodak Ektachem 950 IRC (34087) Medica EasyLyte Calcium Analyzer Kodak Ektachem DT II (34057) (40197) LSI ASCA Chemistry System (37069) Nova 16 (43103) LSI ASCA Chemistry System (37069) ANALYTE: Calcium, Ionized (1004) Olympus AU 5041 (46145) Nova 10 (with CRT) (43061) TEST SYSTEM, ASSAY OR Olympus AU 5121 (46087) Nova 16 (43103) EXAMINATION: Olympus AU 5200 (46143) Nova Stat Profile 9 (43086) AVL 988–4 (04556) Schiapparelli Biosystems ACE Clinical Nova Stat Profile Plus 10 (43063) Ciba Corning 850 (10251) Chemistry System (58288) Olympus AU 5041 (46145) Ciba Corning 855 (10297) Technicon OPERA Clinical Chemistry Olympus AU 5200 (46143) Ciba Corning 860 (10269) System (61161) PrismaSystems PROCHEM (49105) Ciba Corning 865 (10298) Radiometer ABL 620 (55137) ANALYTE: Carcinoembryonic Antigen (CEA) Diametrics Medical IRMA Blood Analysis Radiometer EML 100 (55134) (1013) System (13362) Schiapparelli Biosystems ACE Clinical TEST SYSTEM, ASSAY OR I-STAT i-STAT 200 System (28344) Chemistry System (58288) EXAMINATION: I-STAT i-STAT Portable Clinical Analyzer Synermed IR 500 (58322) Boehringer Mannheim ES 300 (07160) (28186) Technicon OPERA Clinical Chemistry TOSOH A1A–600 (61039) Instrumentation Laboratory Blood Gas System (61161) 1640 (28338) ANALYTE: Cerebrospinal Fluid (CSF) ANALYTE: Chloride, Sweat (Cystic Fibrosis Ionetics Model 400/450 Electrolyte Protein (1014) Sweat Test) (1019) Analyzer (28324) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR Medica EasyLyte Calcium Analyzer EXAMINATION: EXAMINATION: (40197) Beckman Synchron CX 4 (07071) Scandipharm CF Indicator (9800) (58240) Nova Stat Profile 9 (43086) Beckman Synchron CX 4 CE (07174) Beckman Synchron CX 5 (07072) ANALYTE: Cholesterol (1020) Nova Stat Profile Ultra 11P Analyzer TEST SYSTEM, ASSAY OR (43101) Beckman Synchron CX 7 (07073) Boehringer Mannheim Hitachi 704 (07161) EXAMINATION: Radiometer ABL 620 (55137) Abbott Spectrum CCX (04515) Radiometer EML 100 (55134) Boehringer Mannheim Hitachi 717 (07163) Boehringer Mannheim Hitachi 747 (07166) Beckman Synchron CX 5 CE (07491) ANALYTE: Calcium, Total (1005) Boehringer Mannheim Hitachi 914 (07546) Boehringer Mannheim Hitachi 911 (07377) TEST SYSTEM, ASSAY OR Du Pont ACA Star (13357) Du Pont ACA Star (13357) EXAMINATION: Du Pont Dimension XL (13355) Du Pont Dimension (13086) Abbott Spectrum CCX (04515) Instrumentation Laboratory ILAB 1800 Du Pont Dimension AR (13087) Beckman Synchron AS–X (07069) (28323) Du Pont Dimension ES (13215) Beckman Synchron CX 3 Delta (07548) Instrumentation Laboratory ILAB 900 Du Pont Dimension XL (13355) Beckman Synchron CX 5 CE (07491) (28322) Kodak Ektachem 550 XRC Analyzer Boehringer Mannheim Hitachi 914 (07546) Kodak Ektachem 550 XRC Analyzer (34056) Du Pont ACA Star (13357) (34056) Kodak Ektachem 700 Analyzer C Series Du Pont Dimension XL (13355) Kodak Ektachem 700 Analyzer C Series (34054) Instrumentation Laboratory ILAB 1800 (34054) Kodak Ektachem 750 XRC Analyzer (28323) Kodak Ektachem 750 XRC Analyzer (34055) Instrumentation Laboratory ILAB 900 (34055) Kodak Ektachem 950 IRC (34087) (28322) Kodak Ektachem 950 IRC (34087) Kodak Ektachem 550 XRC Analyzer ANALYTE: Ceruloplasmin (1015) Kodak Ektachem DT II (34057) (34056) TEST SYSTEM, ASSAY OR LSI ASCA Chemistry System (37069) Kodak Ektachem 700 Analyzer C Series EXAMINATION: Olympus AU 5041 (46145) (34054) Behring Nephelometer II (07563) Olympus AU 5200 (46143) Kodak Ektachem 750 XRC Analyzer ANALYTE: Chloride (1018) PrismaSystems PROCHEM (49105) (34055) TEST SYSTEM, ASSAY OR Schiapparelli Biosystems ACE Clinical Kodak Ektachem 950 IRC (34087) EXAMINATION: Chemistry System (58288) Kodak Ektachem DT II (34057) Beckman Synchron CX 3 Delta (07548) StatChem StatTest Sysem (58269) LSI ASCA Chemistry System (37069) Beckman Synchron CX 5 CE (07491) Technicon OPERA Clinical Chemistry Nova 10 (with CRT) (43061) Boehringer Mannheim Hitachi 914 (07546) System (61161) Olympus AU 5041 (46145) Ciba Corning 850 (10251) ANALYTE: Cholinesterase (1021) Olympus AU 5200 (46143) Ciba Corning 855 (10297) TEST SYSTEM, ASSAY OR PrismaSystems PROCHEM (49105) Ciba Corning 860 (10269) EXAMINATION: Schiapparelli Biosystems ACE Clinical Ciba Corning 865 (10298) Beckman Synchron CX 5 CE (07491) Chemistry System (58288) Du Pont ACA Star (13357) Boehringer Mannheim Hitachi 911 (07377) Synermed IR 500 (58322) Du Pont Dimension XL (13355) Boehringer Mannheim Hitachi 914 (07546) 25954 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

Kodak Ektachem 550 XRC Analyzer Sanofi Pasteur Access Immunoassay Ciba Corning ACS 180 (10046) (34056) System (58257) Sanofi Pasteur Access Immunoassay Kodak Ektachem 700 Analyzer C Series ANALYTE: Creatinine (1035) System (58257) (34054) TEST SYSTEM, ASSAY OR ANALYTE: Fructosamine (1914) Kodak Ektachem 750 XRC Analyzer EXAMINATION: TEST SYSTEM, ASSAY OR (34055) Abbott Spectrum CCX (04515) EXAMINATION: Kodak Ektachem 950 IRC (34087) Beckman Synchron CX 3 Delta (07548) Boehringer Mannheim Hitachi 736 (07164) Kodak Ektachem DT II (34057) Boehringer Mannheim Hitachi 914 (07546) Boehringer Mannheim Hitachi 914 (07546) Technicon Chem 1 (61003) Du Pont ACA Star (13357) ANALYTE: Gamma Glutamyl Transferase Technicon Chem 1 Plus (61036) Du Pont Dimension XL (13355) (GGT) (2201) ANALYTE: Creatine Kinase (CK) (1034) Instrumentation Laboratory ILAB 1800 TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR (28323) EXAMINATION: EXAMINATION: Instrumentation Laboratory ILAB 900 Abbott Spectrum CCX (04515) Abbott Spectrum CCX (04515) (28322) Beckman Synchron CX 5 CE (07491) Kodak Ektachem 550 XRC Analyzer Beckman Synchron CX 5 CE (07491) Boehringer Mannheim Hitachi 914 (07546) (34056) Boehringer Mannheim Hitachi 914 (07546) Du Pont ACA Star (13357) Kodak Ektachem 700 Analyzer C Series Du Pont Dimension XL (13355) Du Pont ACA Star (13357) (34054) Du Pont Dimension XL (13355) Instrumentation Laboratory ILAB 1800 Kodak Ektachem 750 XRC Analyzer (28323) Instrumentation Laboratory ILAB 1800 (34055) (28323) Instrumentation Laboratory ILAB 900 Kodak Ektachem 950 IRC (34087) (28322) Instrumentation Laboratory ILAB 900 Kodak Ektachem DT II (34057) (28322) Kodak Ektachem 550 XRC Analyzer LSI ASCA Chemistry System (37069) (34056) Kodak Ektachem 550 XRC Analyzer Nova 16 (43103) (34056) Kodak Ektachem 700 Analyzer C Series Olympus AU 5041 (46145) (34054) Kodak Ektachem 700 Analyzer C Series Olympus AU 5121 (46087) Kodak Ektachem 750 XRC Analyzer (34054) Olympus AU 5200 (46143) (34055) Kodak Ektachem 750 XRC Analyzer PrismaSystems PROCHEM (49105) Kodak Ektachem 950 IRC (34087) (34055) Schiapparelli Biosystems ACE Clinical Kodak Ektachem DT II (34057) Kodak Ektachem 950 IRC (34087) Chemistry System (58288) LSI ASCA Chemistry System (37069) Kodak Ektachem DT II (34057) Synermed IR 500 (58322) Olympus AU 5041 (46145) LSI ASCA Chemistry System (37069) Technicon OPERA Clinical Chemistry Olympus AU 5200 (46143) Olympus AU 5041 (46145) System (61161) PrismaSystems PROCHEM (49105) Olympus AU 5121 (46087) ANALYTE: Ferritin (1902) Schiapparelli Biosystems ACE Clinical Olympus AU 5200 (46143) TEST SYSTEM, ASSAY OR Chemistry System (58288) PB Diagnostics Systems OPUS (49001) EXAMINATION: Technicon OPERA Clinical Chemistry PB Diagnostics Systems OPUS Magnum Abbott AxSYM (04532) System (61161) (49097) Bio-Rad RADIAS System (07493) ANALYTE: Glucose (2203) PB Diagnostics Systems OPUS PLUS Boehringer Mannheim ES 300 AL (07524) TEST SYSTEM, ASSAY OR (49098) Cirrus Diagnostics Immulite (10159) EXAMINATION: Schiapparelli Biosystems ACE Clinical Du Pont ACA III with aca plus Abaxis EPOC 2000 (04547) Chemistry System (58288) Immunoassay System (13253) Abbott Spectrum CCX (04515) Technicon OPERA Clinical Chemistry Du Pont ACA IV with aca plus Beckman Synchron CX 3 Delta (07548) System (61161) Immunoassay System (13254) Beckman Synchron CX 5 CE (07491) Du Pont ACA Star with aca plus ANALYTE: Creatine Kinase MB Fraction Boehringer Mannheim Hitachi 914 (07546) Immunoassay System (13358) (CKMB) (1002) Cholestech L.D.X. (10170) Du Pont ACA V with aca plus TEST SYSTEM, ASSAY OR Ciba Corning 860 (10269) Immunoassay System (13255) EXAMINATION: Ciba Corning 865 (10298) Olympus Reply (46089) Abbott AxSYM (04532) Du Pont ACA Star (13357) PB Diagnostics Systems OPUS Magnum Beckman Synchron CX 5 CE (07491) Du Pont Dimension XL (13355) (49097) Boehringer Mannheim Hitachi 914 (07546) I–STAT i–STAT 200 System (28344) PB Diagnostics Systems OPUS PLUS Du Pont ACA Star (13357) Instrumentation Laboratory ILAB 1800 (49098) Du Pont ACA Star with aca plus (28323) Roche Cobas Core (55119) Immunoassay System (13358) Instrumentation Laboratory ILAB 900 Roche Cobas FARA (55040) Du Pont Dimension XL (13355) (28322) Roche Cobas FARA II (55041) Kodak Ektachem 550 XRC Analyzer Kodak Ektachem 550 XRC Analyzer Roche Cobas Mira Plus (55096) (34056) (34056) Sanofi Pasteur Access Immunoassay Kodak Ektachem 700 Analyzer C Series Kodak Ektachem 700 Analyzer C Series System (58257) (34054) (34054) Seradyn LPIA–100 (58294) Kodak Ektachem 750 XRC Analyzer Kodak Ektachem 750 XRC Analyzer Syva Vista Immunoassay System (58221) (34055) (34055) Vitek Systems Vidas (67038) Kodak Ektachem 950 IRC (34087) Kodak Ektachem 950 IRC (34087) Kodak Ektachem DT II 34057) ANALYTE: Folate (Folic acid) (1907) Kodak Ektachem DT II (34057) LSI ASCA Chemistry System (37069) TEST SYSTEM, ASSAY OR LSI ASCA Chemistry System (37069) PB Diagnostics Systems OPUS Magnum EXAMINATION: Nova 16 (43103) (49097) Bio-Rad RADIAS System (07493) Nova Stat Profile 9 (43086) PB Diagnostics Systems OPUS PLUS Boehringer Mannheim Hitachi 911 (07377) Nova Stat Profile Plus 10 (43063) (49098) Cirrus Diagnostics Immulite (10159) Nova Stat Profile Ultra 11P Analyzer Princeton BioMeditech AccuSign MI CK– Roche Cobas Mira Plus (55096) (43101) MB/Myoglobin (49143) Sanofi Pasteur Access Immunoassay Olympus AU 5041 (46145) Princeton BioMeditech CarePoint MI CK– System (58257) Olympus AU 5121 (46087) MB/Myoglobin (49141) Syva Vista Immunoassay System (58221) Olympus AU 5200 (46143) Princeton BioMeditech LifeSign MI CK– ANALYTE: Folate, Red Blood Cell (RBC PrismaSystems PROCHEM (49105) MB/Myoglobin (49140) Folate) (1930) Schiapparelli Biosystems ACE Clinical Princeton BioMeditech VitalSign MI CK– TEST SYSTEM, ASSAY OR Chemistry System (58288) MB/Myoglobin (49142) EXAMINATION: StatChem StatTest System (58269) Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25955

Synermed IR 500 (58322) Beckman Synchron AS Xi (MHS SPINPRO) Ciba Corning 570 Alliance (MHS Technicon OPERA Clinical Chemistry (07573) SPINPRO) (10275) System (61161) Beckman Synchron CX 4 (DMA One Shots) Ciba Corning 580 Alliance (MHS Yellow Springs YSI Model 23A Blood (07620) SPINPRO) (10276) Glucose Analyzer (76006) Beckman Synchron CX 4 (MHS SPINPRO) Coulter Dacos (DMA One Shots) (10292) ANALYTE: Glycosylated Hemoglobin (Hgb (07574) Coulter Dacos (T-Am. Singles) (10277) A1C) (2204) Beckman Synchron CX 4 CE (DMA One Coulter Optichem (T-Am. Singles) (10278) TEST SYSTEM, ASSAY OR Shots) (07621) Coulter Optichem 100 (DMA One Shots) EXAMINATION: Beckman Synchron CX 4 CE (MHS (10293) Abbott IMX (04056) SPINPRO) (07575) Du Pont ACA (DMA One Shots) (13365) Beckman Synchron CX 4 (07071) Beckman Synchron CX 5 (DMA One Shots) Du Pont ACA (MHS SPINPRO) (13346) Beckman Synchron CX 5 (07072) (07622) Du Pont ACA II (DMA One Shots) (13366) Beckman Synchron CX 7 (07073) Beckman Synchron CX 5 (MHS SPINPRO) Du Pont ACA II (MHS SPINPRO) (13347) Bio-Rad RADIAS System (07493) (07576) Du Pont ACA III (DMA One Shots) (13367) Bio-Rad Variant (07498) Beckman Synchron CX 5 (T-Am. Singles) Du Pont ACA III (MHS SPINPRO) (13348) Boehringer Mannheim Hitachi 704 (07161) (07577) Du Pont ACA IV (DMA One Shots) (13368) Boehringer Mannheim Hitachi 717 (07163) Beckman Synchron CX 5 CE (DMA One Du Pont ACA IV (MHS SPINPRO) (13349) Boehringer Mannheim Hitachi 747 (07166) Shots) (07623) Du Pont ACA V (DMA One Shots) (13369) Boehringer Mannheim Hitachi 911 (07377) Beckman Synchron CX 7 (DMA One Shots) Du Pont ACA V ((MHS SPINPRO) (13350) Boehringer Mannheim Hitachi 914 (07546) (07624) Du Pont Analyst (DMA One Shots) (13364) Roche Cobas FARA (55040) Beckman Synchron CX 7 (MHS SPINPRO) Du Pont Analyst (MHS SPINPRO) (13351) Roche Cobas Mira (55044) (07578) Du Pont Dimension (DMA One Shots) Beckman Synchron CX 7 (T-Am. Singles) (13370) ANALYTE: HDL Cholesterol (2550) (07579) Du Pont Dimension (MHS SPINPRO) TEST SYSTEM, ASSAY OR Bio-Chem Laboratory Systems ATAC 2000/ (13352) EXAMINATION: 2100 (DMA One Shots) (07634) Du Pont Dimension AR (DMA One Shots) Abbott Spectrum (DMA One Shots) (04598) Bio-Chem Laboratory Systems ATAC 6000 (13371) Abbott Spectrum (MHS SPINPRO) (04563) (DMA One Shots) (07626) Du Pont Dimension AR (MHS SPINPRO) Abbott Spectrum (T-Am. Singles) (04588) Bio-Chem Laboratory Systems ATAC 6000 (13353) Abbott Spectrum CCX (DMA One Shots) (T-Am. Singles) (07596) Du Pont Dimension ES (DMA One Shots) (04599) BioAutoMed ASCA (07192) (13372) Abbott Spectrum CCX (T-Am. Singles) BioAutoMed ASCA (DMA One Shots) Du Pont Dimension ES (MHS SPINPRO) (04587) (07625) (13354) Abbott Spectrum EPX (DMA One Shots) Boehringer Mannheim Hitachi 704 (DMA EM Diagnostic Systems EPOS (DMA One (04600) One Shots) (07627) Shots) (16099) Abbott Spectrum EPX (MHS SPINPRO) Boehringer Mannheim Hitachi 704 (MHS EM Diagnostic Systems EPOS (MHS (04564) Abbott Spectrum EPX (T-Am. Singles) SPINPRO) (07580) SPINPRO) (16094) (04565) Boehringer Mannheim Hitachi 704 (T-Am. Electronucleonics Gem-Profiler (DMA One Abbott Spectrum Series II (DMA One Singles) (07590) Shots) (16095) Shots) (04601) Boehringer Mannheim Hitachi 705 (DMA Electronucleonics Gemini (DMA One Abbott Spectrum Series II (MHS SPINPRO) One Shots) (07628) Shots) (16096) (04566) Boehringer Mannheim Hitachi 705 (MHS Electronucleonics Gemstar (DMA One Abbott Spectrum Series II (T-Am. Singles) SPINPRO) (07581) Shots) (16097) (04589) Boehringer Mannheim Hitachi 705 (T-Am. Electronucleonics Gemstar (T-Am. Singles) Abbott Spectrum Series II CCX (DMA One Singles) (07591) (16093) Shots) (04602) Boehringer Mannheim Hitachi 717 (DMA Electronucleonics Gemstar II (DMA One Abbott Spectrum Series II CCX (MHS One Shots) (07629) Shots) (16098) SPINPRO) (04567) Boehringer Mannheim Hitachi 717 (MHS Instrumentation Laboratory IL Monarch (T- Abbott Spectrum Series II CCX (T-Am. SPINPRO) (07582) Am. Singles) (28361) Singles) (04590) Boehringer Mannheim Hitachi 717 (T-Am. Instrumentation Laboratory IL Monarch Abbott TDX (04071) Singles) (07592) 1000 (DMA One Shots) (28380) Abbott TDX (MHS SPINPRO) (04568) Boehringer Mannheim Hitachi 736 (DMA Instrumentation Laboratory IL Monarch Abbott TDX FLx (04072) One Shots) (07630) 1000 (T-Am. Singles) (28362) Abbott TDX FLx (MHS SPINPRO) (04569) Boehringer Mannheim Hitachi 736 (MHS Instrumentation Laboratory IL Monarch Abbott VP (DMA One Shots) (04603) SPINPRO) (07583) 2000 (DMA One Shots) (28381) Abbott VP (MHS SPINPRO) (04570) Boehringer Mannheim Hitachi 736 (T-Am. Instrumentation Laboratory IL Monarch Abbott Vision, Non Whole Blood HDL Singles) (07593) 2000 (T-Am. Singles) (28363) Procedure (04451) Boehringer Mannheim Hitachi 737 (DMA Instrumentation Laboratory IL Monarch Abbott Vision, Non Whole Blood HDL One Shots) (07631) Plus (DMA One Shots) (28382) Procedure (MHS SPINPRO) (04571) Boehringer Mannheim Hitachi 737 (MHS Instrumentation Laboratory IL Monarch Ames Seralyzer (DMA One Shots) (04604) SPINPRO) (07584) Plus (T-Am. Singles) (28364) Ames Seralyzer III (DMA One Shots) Boehringer Mannheim Hitachi 737 (T-Am. Kodak Ektachem 250 (DMA One Shots) (04605) Singles) (07594) (34076) Baxter Paramax (DMA One Shots) (07618) Boehringer Mannheim Hitachi 747 (DMA Kodak Ektachem 250 (MHS SPINPRO) Baxter Paramax (MHS SPINPRO) (07566) One Shots) (07632) (34063) Baxter Paramax 720 ZX (DMA One Shots) Boehringer Mannheim Hitachi 747 (MHS Kodak Ektachem 400 (DMA One Shots) (07619) SPINPRO) (07585) (34077) Baxter Paramax 720 ZX (MHS SPINPRO) Boehringer Mannheim Hitachi 747 (T-Am. Kodak Ektachem 400 (MHS SPINPRO) (07567) Singles) (07595) (34064) Beckman Astra 8 (MHS SPINPRO) (07568) Boehringer Mannheim Hitachi 911 (MHS Kodak Ektachem 500 (DMA One Shots) Beckman Astra 8e (MHS SPINPRO) (07569) SPINPRO) (07586) (34078) Beckman Astra Ideal (MHS SPINPRO) Ciba Corning 550 Express (DMA One Kodak Ektachem 500 (MHS SPINPRO) (07570) Shots) (10291) (34065) Beckman Synchron AS–X (MHS SPINPRO) Ciba Corning 550 Express (MHS SPINPRO) Kodak Ektachem 550 XRC Analyzer (07571) (10274) (34056) Beckman Synchron AS–Xe (MHS Ciba Corning 550 Express (T-Am. Singles) Kodak Ektachem 550 XRC Analyzer (DMA SPINPRO) (07572) (10273) One Shots) (34079) 25956 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

Kodak Ektachem 700 (DMA One Shots) Roche Cobas FARA II (DMA One Shots) Boehringer Mannheim Hitachi 914 (07546) (34080) (55154) ANALYTE: Lactate Dehydrogenase (LDH) Kodak Ektachem 700 (MHS SPINPRO) Roche Cobas Fara (MHS SPINPRO) (55141) (3701) (34066) Roche Cobas Fara (T–Am. Singles) (55144) TEST SYSTEM, ASSAY OR Kodak Ektachem 700 Analyzer C Series Roche Cobas MIRA (DMA One Shots) EXAMINATION: (34054) (55155) Abbott Spectrum CCX (04515) Kodak Ektachem 700 Analyzer C Series Roche Cobas MIRA Plus (DMA One Shots) Beckman Synchron CX 5 CE (07491) (DMA One Shots) (34081) (55156) Boehringer Mannheim Hitachi 914 (07546) Kodak Ektachem 700 P (DMA One Shots) Roche Cobas MIRA S (DMA One Shots) Du Pont ACA Star (13357) (34082) (55157) Du Pont Dimension XL (13355) Kodak Ektachem 700 P (MHS SPINPRO) Roche Cobas Mira (MHS SPINPRO) (55142) Kodak Ektachem 550 XRC Analyzer (34067) Roche Cobas Mira (T–Am. Singles) (55145) (34056) Kodak Ektachem 700 XR (DMA One Shots) Schiapparelli Biosystems ACE (DMA One Kodak Ektachem 700 Analyzer C Series (34083) Shots) (58357) (34054) Kodak Ektachem 700 XR (MHS SPINPRO) Kodak Ektachem 750 XRC Analyzer (34068) Schiapparelli Biosystems ACE Clinical Chemistry System (58288) (34055) Kodak Ektachem 750 XRC (DMA One Kodak Ektachem 950 IRC (34087) Shots) (34084) Technicon Assist (DMA One Shots) (61181) Kodak Ektachem DT II (34057) Kodak Ektachem 750 XRC Analyzer LSI ASCA Chemistry System (37069) (34055) Technicon RA 100 (DMA One Shots) Olympus AU 5041 (46145) Kodak Ektachem 950 IRC (34087) (61182) Olympus AU 5121 (46087) Kodak Ektachem DT 60 (DMA One Shots) Technicon RA 1000 (DMA One Shots) Olympus AU 5200 (46143) (34085) (61183) PrismaSystems PROCHEM (49105) Kodak Ektachem DT 60 (MHS SPINPRO) Technicon RA 1000 (MHS SPINPRO) Schiapparelli Biosystems ACE Clinical (34069) (61162) Chemistry System (58288) Kodak Ektachem DT II (34057) Technicon RA 1000 (T–Am. Singles) Synermed IR 500 (58322) Kodak Ektachem DT II (DMA One Shots) (61164) Technicon OPERA Clinical Chemistry (34086) Technicon RA 2000 (DMA One Shots) System (61161) LSI ASCA Chemistry System (37069) (61184) LSI ASCA Chemistry System (DMA One Technicon RA 500 (DMA One Shots) ANALYTE: Lactate Dehydrogenase Heart Shots) (37096) (61185) Fraction (LDH–1) (3702) LSI ASCA Chemistry System (T-Am. Technicon RA 500 (T–Am. Singles) (61163) TEST SYSTEM, ASSAY OR Singles) (37095) Technicon RA XT (DMA One Shots) EXAMINATION: Olympus AU 5000 (DMA One Shots) (61186) Abbott Spectrum CCX (04515) (46173) Technicon RA XT (T–Am. Singles) (61165) Boehringer Mannheim Hitachi 914 (07546) Olympus AU 5021 (DMA One Shots) Du Pont ACA Star (13357) ANALYTE: Haptoglobin (2511) (46174) TEST SYSTEM, ASSAY OR ANALYTE: Lactate Dehydrogenase Liver Olympus AU 5031 (DMA One Shots) EXAMINATION Fraction (LLDH) 3703) (46175) Behring Nephelometer II (07563) TEST SYSTEM, ASSAY OR Olympus AU 5041 (DMA One Shots) EXAMINATION: (46176) ANALYTE: Hemoglobin S (2536) Du Pont ACA Star (13357) Olympus AU 5061 (DMA One Shots) TEST SYSTEM, ASSAY OR Instrumentation Laboratory ILAB 1800 (46177) EXAMINATION: (28323) Olympus AU 5121 (DMA One Shots) Histo-Med Sickle Cell Reagent Set (25164) Instrumentation Laboratory ILAB 900 (46178) ANALYTE: Iron (2814) (28322) Olympus AU 5131 (DMA One Shots) TEST SYSTEM, ASSAY OR ANALYTE: Lactic Acid (Lactate) (3704) (46179) EXAMINATION: TEST SYSTEM, ASSAY OR Olympus AU 5200 (DMA One Shots) Abbott Spectrum CCX (04515) EXAMINATION: (46180) Beckman Synchron CX 5 CE (07491) Beckman Synchron CX 5 CE (07491) Olympus AU 5211 (DMA One Shots) Boehringer Mannheim Hitachi 914 (07546) Boehringer Mannheim Hitachi 914 (07546) (46181) Du Pont ACA Star (13357) Ciba Corning 860 (10269) Olympus AU 5221 (DMA One Shots) Du Pont Dimension XL (13355) Ciba Corning 865 (10298) (46182) Instrumentation Laboratory ILAB 1800 Du Pont ACA Star (13357) Olympus AU 5223 (DMA One Shots) (28323) Du Pont Dimension XL (13355) (46183) Instrumentation Laboratory ILAB 900 Kodak Ektachem 550 XRC Analyzer Olympus AU 5231 (DMA One Shots) (28322) (46184) (34056) Kodak Ektachem 550 XRC Analyzer Kodak Ektachem 700 Analyzer C Series Olympus AU 800 (DMA One Shots) (34056) (46185) (34054) Kodak Ektachem 700 Analyzer C Series Kodak Ektachem 750 XRC Analyzer Olympus AU 5000 (MHS SPINPRO) (34054) (46161) (34055) Kodak Ektachem 750 XRC Analyzer Olympus AU 5000 (T-Am. Singles) (46166) Kodak Ektachem 950 IRC (34087) (34055) Olympus Demand (DMA One Shots) Kodak Ektachem DT II (34057) Kodak Ektachem 950 IRC (34087) (46186) Nova Stat Profile 9 (43086) Kodak Ektachem DT SC Module (34017) Olympus Demand (MHS SPINPRO) (46162) Nova Stat Profile Plus 10 (43063) LSI ASCA Chemistry System (37069) Olympus Demand (T–Am. Singles) (46164) Nova Stat Profile Ultra 11P Analyzer Olympus Reply (DMA One Shots) (46187) Olympus AU 5041 (46145) (43101) Olympus Reply (MHS SPINPRO) (46163) Olympus AU 5200 (46143) Technicon OPERA Clinical Chemistry Olympus Reply (T–Am. Singles) (46165) PrismaSystems PROCHEM (49105) System (61161) Olympus Reply/AU560 (DMA One Shots) Schiapparelli Biosystems ACE Clinical Yellow Springs YSI Model 23L Blood (46188) Chemistry System (58288) Lactoat Analyzer (76007) PrismaSystems PROCHEM (49105) Technicon OPERA Clinical Chemistry ANALYTE: Lactoferrin (3727) Roche Cobas Bio (DMA One Shots) (55152) System (61161) TEST SYSTEM, ASSAY OR Roche Cobas Bio (MHS SPINPRO) (55140) ANALYTE: Iron Binding Capacity, Unsat. EXAMINATION: Roche Cobas Bio (T–Am. Singles) (55143) (UIBC) no pretreat. (2823) TechLab LEUKO–TEST (61133) Roche Cobas FARA (DMA One Shots) TEST SYSTEM, ASSAY OR Touch Scientific LactoCard Tear (55153) EXAMINATION: Lactoferrin Immunoassay (61110) Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25957

Touch Scientific Lactoferrin MicroAssay Beckman Synchron CX 4 CE (07174) PrismaSystems PROCHEM (49105) System (61137) Beckman Synchron CX 5 CE (07491) Schiapparelli Biosystems ACE Clinical ANALYTE: Leucine Aminopeptidase (LAP) Beckman Synchron CX 7 (07073) Chemistry System (58288) (3709) Boehringer Mannheim Hitachi 914 (07546) Synermed IR 500 (58322) TEST SYSTEM, ASSAY OR Olympus AU 5041 (46145) Technicon OPERA Clinical Chemistry EXAMINATION: Olympus AU 800 (46110) System (61161) Beckman Synchron CX 5 CE (07491) ANALYTE: Microprotein, Urine (4027) ANALYTE: Potassium (4910) ANALYTE: Lipase (3711) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR EXAMINATION: EXAMINATION: EXAMINATION: Beckman Synchron CX 4 CE (07174) AVL 988–4 (04556) Boehringer Mannheim Hitachi 914 (07546) Beckman Synchron CX 5 CE (07491) American Monitor Parallel (04144) Du Pont ACA Star (13357) Beckman Synchron CX 7 (07073) Beckman Synchron CX 3 Delta (07548) Du Pont Dimension XL (13355) Boehringer Mannheim Hitachi 914 (07546) Beckman Synchron CX 5 CE (07491) Kodak Ektachem 550 XRC Analyzer Olympus AU 5041 (46145) Boehringer Mannheim Hitachi 914 (07546) (34056) Olympus AU 800 (46110) Ciba Corning 850 (10251) Kodak Ektachem 700 Analyzer C Series ANALYTE: Myoglobin (4023) Ciba Corning 855 (10297) (34054) TEST SYSTEM, ASSAY OR Ciba Corning 860 (10269) Kodak Ektachem 750 XRC Analyzer EXAMINATION: Ciba Corning 865 (10298) (34055) Behring Nephelometer II (07563) Diametrics Medical IRMA Blood Analysis Kodak Ektachem 950 IRC (34087) PB Diagnostics Systems OPUS Magnum System (13362) Kodak Ektachem DT 60 (34016) (49097) Du Pont Dimension XL (13355) Kodak Ektachem DT II (34057) PB Diagnostics Systems OPUS PLUS I–STAT i-STAT 200 System (28344) LSI ASCA Chemistry System (37069) (49098) Instrumentation Laboratory Blood Gas Olympus AU 5041 (46145) Princeton BioMeditech AccuSign MI CK– 1630 (28337) Instrumentation Laboratory Blood Gas ANALYTE: Magnesium (4002) MB/Myoglobin (49143) 1640 (28338) TEST SYSTEM, ASSAY OR Princeton BioMeditech CarePoint MI CK– Instrumentation Laboratory Blood Gas EXAMINATION: MB/Myoglobin (49141) 1650 (28339) Abbott Spectrum CCX (04515) Princeton BioMeditech LifeSign MI CK– Instrumentation Laboratory IL 1430 Beckman Synchron CX 5 CE (07491) MB/Myoglobin (49140) BGElectrolyte (28343) Boehringer Mannheim Hitachi 914 (07546) Princeton BioMeditech LifeSign MI Instrumentation Laboratory ILAB 1800 Du Pont ACA Star (13357) Myoglobin (49122) (28323) Du Pont Dimension XL (13355) Princeton BioMeditech VitalSign MI CK– Instrumentation Laboratory ILAB 900 Instrumentation Laboratory ILAB 1800 MB/Myoglobin (49142) (28322) (28323) ANALYTE: Osmolality, Serum (4602) Instrumentation Laboratory ILye Na, K, Cl Instrumentation Laboratory ILAB 900 TEST SYSTEM, ASSAY OR System (28320) (28322) EXAMINATION: Instrumentation Laboratory ILye Na, K, Li Kodak Ektachem 550 XRC Analyzer Advanced Instruments Model 3D3 System (28319) (34056) Osmometer (04520) Ionetics Model 400/450 Electrolyte Kodak Ektachem 700 Analyzer C Series ANALYTE: Osmolality, Urine (4603) Analyzer (28324) (34054) TEST SYSTEM, ASSAY OR Kodak Ektachem 550 XRC Analyzer Kodak Ektachem 750 XRC Analyzer EXAMINATION: (34056) (34055) Advanced Instruments Model 3D3 Kodak Ektachem 700 Analyzer C Series Kodak Ektachem 950 IRC (34087) Osmometer (04520) (34054) Kodak Ektachem DT II (34057) ANALYTE: Oxyhemoglobin/Oxygen Kodak Ektachem 750 XRC Analyzer LSI ASCA Chemistry System (37069) Saturation (4604) (34055) Nova 8 (43022) TEST SYSTEM, ASSAY OR Kodak Ektachem 950 IRC (34087) Olympus AU 5041 (46145) EXAMINATION: Kodak Ektachem DT II (34057) Olympus AU 5121 (46087) Ciba Corning 845 (10296) Medica EasyLyte Calcium Analyzer Olympus AU 5200 (46143) Ciba Corning 855 (10297) (40197) PrismaSystems PROCHEM (49105) Ciba Corning 865 (10298) Nova 10 (with CRT) (43061) Schiapparelli Biosystems ACE Clinical Radiometer ABL 620 (55137) Nova 16 (43103) Chemistry System (58288) Nova 8 (43022) Technicon Chem 1 Plus (61036) ANALYTE: Phosphorus (4906) Nova Stat Profile 9 (43086) Technicon OPERA Clinical Chemistry TEST SYSTEM, ASSAY OR Nova Stat Profile Plus 10 (43063) System (61161) EXAMINATION: Abbott Spectrum CCX (04515) Nova Stat Profile Ultra 11P Analyzer ANALYTE: Magnesium, Ionized (4018) Beckman Synchron CX 5 CE (07491) (43101) TEST SYSTEM, ASSAY OR Boehringer Mannheim Hitachi 914 (07546) Olympus AU 5041 (46145) EXAMINATION: Du Pont ACA Star (13357) Olympus AU 5200 (46143) AVL 988–4 (04556) Du Pont ACA Dimension XL (13355) PDX Stat K Rapid Potassium Test System Nova Stat Profile Ultra 11P Analyzer Instrumentation Laboratory ILAB 1800 (49102) (43101) (28323) PrismaSystems PROCHEM (49105) ANALYTE: Methemoglobin (4032) Instrumentation Laboratory ILAB 900 Radiometer ABL 620 (55137) TEST SYSTEM, ASSAY OR (28322) Radiometer EML 100 (55134) EXAMINATION: Kodak Ektachem 550 XRC Analyzer Schiapparelli Biosystems ACE Clinical Ciba Corning 845 (10296) (34056) Chemistry System (58288) Ciba Corning 855 (10297) Kodak Ektachem 700 Analyzer C Series StatChem StatTest Sysem (58269) Ciba Corning 865 (10298) (34054) Synermed IR 500 (58322) ANALYTE: Microalbumin (4019) Kodak Ektachem 750 XRC Analyzer Technicon OPERA Clinical Chemistry TEST SYSTEM, ASSAY OR (34055) System (61161) EXAMINATION: Kodak Ektachem 950 IRC (34087) ANALYTE: Prealbumin (4911) Boehringer Mannheim Hitachi 747 (07166) Kodak Ektachem DT II (34057) TEST SYSTEM, ASSAY OR Boehringer Mannheim Hitachi 911 (07377) LSI ASCA Chemistry System (37069) EXAMINATION: ANALYTE: Microprotein, CSF (4026) Olympus AU 5041 (46145) Behring Nephelometer II (07563) TEST SYSTEM, ASSAY OR Olympus AU 5121 (46087) ANALYTE: Prostatic Acid Phosphatase (PAP) EXAMINATION: Olympus AU 5200 (46143) (4918) 25958 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

TEST SYSTEM, ASSAY OR Ciba Corning 855 (10297) Beckman Synchron CX 4 CE (07174) EXAMINATION: Ciba Corning 860 (10269) Beckman Synchron CX 5 CE (07491) Cirrus Diagnostics Immulite (10159) Ciba Corning 865 (10298) Boehringer Mannheim Hitachi 914 (07546) ANALYTE: Prostatic Specific Antigen (PSA) Diametrics Medical IRMA Blood Analysis Du Pont ACA Star (13357) (4919) System (13362) Du Pont Dimension XL (13355) TEST SYSTEM, ASSAY OR Du Pont Dimension XL (13355) Instrumentation Laboratory ILAB 1800 EXAMINATION: I-STAT i-STAT 200 System (28344) (28323) TOSOH A1A–1200 (61040) Instrumentation Laboratory Blood Gas Instrumentation Laboratory ILAB 900 1630 (28337) ANALYTE: Protein, Total (4921) (28322) Instrumentation Laboratory Blood Gas TEST SYSTEM, ASSAY OR Kodak Ektachem 550 XRC Analyzer 1640 (28338) EXAMINATION: (34056) Instrumentation Laboratory Blood Gas Abaxis EPOC 2000 (04547) Kodak Ektachem 700 Analyzer C Series 1650 (28339) Abott Spectrum CCX (04515) (34054) Instrumentation Laboratory IL 1430 Beckman Synchron CX 3 Delta (07548) Kodak Ektachem 750 XRC Analyzer BGElectrolyte (28343) Beckman Synchron CX 4 CE (07174) (34055) Instrumentation Laboratory ILAB 1800 Beckman Synchron CX 5 CE (07491) Kodak Ektachem 950 IRC (34087) (28323) Behring Nephelometer II (07563) Kodak Ektachem DT II (34057) Instrumentation Laboratory ILAB 900 Boehringer Mannheim Hitachi 914 (07546) LSI ASCA Chemistry System (37069) (28322) Du Pont ACA Star (13357) Olympus AU 5041 (46145) Instrumentation Laboratory ILyte Na, K, Cl Du Pont Dimension XL (13355) Olympus AU 5121 (46087) System (28320) Instrumentation Laboratory ILAB 1800 Olympus AU 5200 (46143) Instrumentation Laboratory ILyte Na, K, Li (28323) PrismaSystems Prochem (49105) System (28319) Instrumentation Laboratory ILAB 900 Schiapparelli Biosystems ACE Clinical Ionetics Model 400/450 Electrolyte (28322) Chemistry System (58288) Analyzer (28324) Kodak Ektachem 550 XRC Analyzer Technicon OPERA Clinical Chemistry Kodak Ektachem 550 XRC Analyzer (34056) System (61161) (34056) Kodak Ektachem 700 Analyzer C Series Kodak Ektachem 700 Analyzer C Series ANALYTE: Troponin T (Tn T) (6140) (34054) (34054) TEST SYSTEM, ASSAY OR Kodak Ektachem 750 XRC Analyzer Kodak Ektachem 750 XRC Analyzer EXAMINATION: (34055) (34055) Boehringer Mannheim ES 300 (07160) Kodak Ektachem 950 IRC (34087) Kodak Ektachem 950 IRC (34087) ANALYTE: Urea (BUN) (6403) Kodak Ektachem DT II (34057) Kodak Ektachem DT II (34057) TEST SYSTEM, ASSAY OR LSI ASCA Chemistry System (37069) Medica EasyLyte Calcium Analyzer EXAMINATION: Olympus AU 5041 (46145) (40197) Abbott Spectrum CCX (04515) Olympus AU 5121 (46087) Nova 10 (with CRT) (43061) Beckman Synchron CX 3 Delta (07548) Olympus AU 5200 (46143) Nova 16 (43103) Beckman Synchron CX 4 CE (07174) PrismaSystems PROCHEM (49105) Nova 8 (43022) Beckman Synchron CX 5 CE (07491) Schiapparelli Biosystems ACE Clinical Nova Stat Profile 9 (43086) Boehringer Mannheim Hitachi 914 (07546) Chemistry System (58288) Nova Stat Profile Plus 10 (43063) Du Pont ACA Star (13357) Synermed IR 500 (58322) Nova Stat Profile Ultra 11P Analyzer Du Pont Dimension XL (13355) Technicon OPERA Clinical Chemistry (43101) System (61161) I-STAT i-STAT 200 System (28344) Olympus AU 5041 (46145) Instrumentation Laboratory ILAB 1800 ANALYTE: Protein, Total (urine) (4972) Olympus AU 5200 (46143) (28323) TEST SYSTEM, ASSAY OR Radiometer ABL 620 (55137) Instrumentation Laboratory ILAB 900 EXAMINATION: Radiometer EML 100 (55134) (28322) Du Pont ACA Star (13357) Schiapparelli Biosystems ACE Clinical Kodak Ektachem 550 XRC Analyzer Du Pont Dimension (13086) Chemistry System (58288) (34056) Du Pont Dimension AR (13087) Synermed IR 500 (58322) Kodak Ektachem 700 Analyzer C Series Du Pont Dimension ES (13215) Technicon OPERA Clinical Chemistry (34054) Du Pont Dimension XL (13355) System (61161) Kodak Ektachem 750 XRC Analyzer ANALYTE: Pseudocholinesterase (4923) ANALYTE: Total Solids (Protein) (6131) (34055) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR Kodak Ektachem 950 IRC (34087) EXAMINATION: EXAMINATION: Kodak Ektachem DT II (34057) Du Pont ACA Star (13357) ATAGO A300CL Clinincal Refractometer LSI ASCA Chemistry System (37069) Du Pont Dimension XL (13355) (04575) Nova 16 (43103) ANALYTE: Reduced Hemoglobin (5523) ATAGO N Serum Protein Refractometer Nova Stat Profile Plus 10 (43063) TEST SYSTEM, ASSAY OR (04574) Olympus AU 5041 (46145) EXAMINATION: ATAGO SP–D Digital Serum Protein Olympus AU 5121 (46087) Ciba Corning 845 (10296) Refractometer (04579) Olympus AU 5200 (46143) Ciba Corning 855 (10297) ATAGO T–2 Clinical Refractometer PrismaSystems PROCHEM (49105) Ciba Corning 865 (10298) (04577) Schiapparelli Biosystems ACE Clinical ANALYTE: Retinol binding protein (5507) National Instrument Hand Protometer Chemistry System (58288) TEST SYSTEM, ASSAY OR (43085) Synermed IR 500 (58322) EXAMINATION: ANALYTE: Transferrin (6114) Technicon OPERA Clinical Chemistry Behring Nephelometer II (07563) TEST SYSTEM, ASSAY OR System (61161) ANALYTE: Sodium (5805) EXAMINATION: ANALYTE: Uric Acid (6404) TEST SYSTEM, ASSAY OR Behring Nephelometer II (07563) TEST SYSTEM, ASSAY OR EXAMINATION: Boehringer Mannheim Hitachi 911 (07377) EXAMINATION: AVL 988–4 (04556) Boehringer Mannheim Hitachi 914 (07546) Abaxis EPOC 2000 (04547) Abbott Vision (04083) Technicon OPERA Clinical Chemistry Abbott Spectrum CCX (04515) American Monitor Parallel (04144) System (61161) Beckman Synchron CX 4 CE (07174) Beckman Synchron CX 3 Delta (07548) ANALYTE: Triglyceride (6118) Beckman Synchron CX 5 CE (07491) Beckman Synchron CX 5 CE (07491) TEST SYSTEM, ASSAY OR Boehringer Mannheim Hitachi 914 (07546) Boehringer Mannheim Hitachi 914 (07546) EXAMINATION: Du Pont ACA Star (13357) Ciba Corning 850 (10251) Abbott Spectrum CCX (04515) Du Pont Dimension XL (13355) Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25959

Instrumentation Laboratory ILAB 1800 J & S Medical Accutex Antistreptolysin O Technicon OPERA Clinical Chemistry (28323) (ASO) Latex Text (31006) System (61161) Instrumentation Laboratory ILAB 900 ANALYTE: Beta-2 microglobulin (0703) ANALYTE: Immunoglobulins IgE (2805) (28322) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR Kodak Ektachem 550 XRC Analyzer EXAMINATION: EXAMINATION: (34056) Beckman Array 360 (07052) Boehringer Mannheim ES 300 AL (07524) Kodak Ektachem 700 Analyzer C Series Cirrus Diagnostics Immulite (10159) Cirrus Diagnostics Immulite (10159) (34054) Du Pont ACA Star (13357) Roche Cobas Core (55119) Kodak Ektachem 750 XRC Analyzer Du Pont ACA V (13084) Sanofi Pasteur Access Immunoassay (34055) Wallac Oy AutoDELFIA (70167) System (58257) Kodak Ektachem 950 IRC (34087) Vitek Systems Vidas (67038) Kodak Ektachem DT II (34057) ANALYTE: C-Reactive Protein (CRP) (1001) LSI ASCA Chemistry System (37069) TEST SYSTEM, ASSAY OR ANALYTE: Immunoglobulins IgG (2806) Olympus AU 5041 (46145) EXAMINATION: TEST SYSTEM, ASSAY OR Olympus AU 5200 (46143) Beckman Synchron CX 5 CE (07491) EXAMINATION: PrismaSystems PROCHEM (49105) Behring Nephelometer II (07563) Beckman Synchron CX 5 CE (07491) Schiapparelli Biosystems ACE Clinical Boehringer Mannheim Hitachi 747 (07166) Behring Nephelometer II (07563) Chemistry System (58288) Boehriner Mannheim Hitachi 914 (07546) Boehringer Mannheim Hitachi 914 (07546) Technicon OPERA Clinical Chemistry Du Pont ACA Star (13357) Du Pont ACA Star (13357) System (61161) Du Pont Dimension XL (13355) Technicon OPERA Clinical Chemistry Immunostics immuno/crp Test (28277) System (61161) ANALYTE: Vitamin B12 (6707) J & S Medical Accutex C-Reactive Protein TEST SYSTEM, ASSAY OR ANALYTE: Immunoglobulins IgG subclasses (CRP) Latex Text (31004) (2807) EXAMINATION: J & S Medical Eye Spot CRP test (31007) Bio-Rad RADIAS System (97493) TEST SYSTEM, ASSAY OR Pulse Scientific C-Reactive Protein (CRP) EXAMINATION: Roche Cobas Mira Plus (55096) Test (49075) Sanofi Pasteur Access Immunoassay Behring Nephelometer (07273) Technicon OPERA Clinical Chemistry Behring Nephelometer 100 (07272) System (58257) System (61161 Syva Vista Immunoassay System (58221) ANALYTE: Immunoglobulins IgM (2808) Technicon Immuno 1 System (61042) ANALYTE: Complement C3 (1029) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR EXAMINATION: SPECIALITY/SUBSPECIALITY: General EXAMINATION: Beckman Synchron CX 5 CE (07491) Immunology Behring Nephelometer II (07563) Behring Nephelometer II (07563) ANALYTE: Allergen specific IgE (0417) Boehringer Mannheim Hitachi 914 (07546) Boehringer Mannheim Hitachi 914 (07546) TEST SYSTEM, ASSAY OR Technicon OPERA Clinical Chemistry Du Pont ACA Star (13357) EXAMINATION: System (61161) Technicon OPERA Clinical Chemistry Cirrus Diagnostic Immulite (10159) ANALYTE: Complement C4 (1030) System (61161) In Vitro Technologies Allergy Profile TEST SYSTEM, ASSAY OR ANALYTE: Infectious Mononucleosis (28279) EXAMINATION: Antibodies (Mono) (2809) Sanofi Pasteur Access Immunoassay Behring Nephelometer II (07563) TEST SYSTEM, ASSAY OR System (58257) Boehringer Mannheim Hitachi 914 (07546) EXAMINATION: ANALYTE: Alpha-1 Microglobin (0470) Technicon OPERA Clinical Chemistry Immunostics immuno/im test (28278) TEST SYSTEM, ASSAY OR System (61161) J & S Medical Accutex Inf. Mono. Red Bld. EXAMINATION: ANALYTE: Cytomegalovirus Antibodies Cell (IM RBC) Test (31003) Beckman Array 360 (07052) (1039) J & S Medical Accutex Infectious Behring Nephelometer II (07563) TEST SYSTEM, ASSAY OR Mononucleosis Latex Test (31008) ANALYTE: Alpha-1-Acid Glycoprotein EXAMINATION: J & S Medical Eye Spot Infectious (orosomucoid) (0420) PB Diagnostics System OPUS (49001) Mononucleosis (IM) Test (31013) TEST SYSTEM, ASSAY OR PB Diagnostics Systems OPUS Magnum Meridian Diagnostics ImmunoCard Mono EXAMINATION: (49097) (40179) Behring Nephelometer II (07563) PB Diagnostics Systems OPUS PLUS Pacific Biotech Concise Plus Mono (49148) Princeton BioMeditech BioSign Mono Test Alpha-1-Antitrypsin (0421) (49098) (49100) TEST SYSTEM, ASSAY OR Vitek Systems Vidas (67038) EXAMINATION: ANALYTE: Helicobacter Pylori Antibodies ANALYTE: Kappa Light Chains (3402) Behring Nephelomoter II (07563) (2513) TEST SYSTEM, ASSAY OR ANALYTE: Alpha-2 Macroglobulin (0422) TEST SYSTEM, ASSAY OR EXAMINATION: TEST SYSTEM, ASSAY OR EXAMINATION: Behring Nephelometer II (07563) EXAMINATION: Meridian Diagnostics ImmunoCard H. ANALYTE: Lambda Light Chains (3705) Behring Nephelometer II (07563) pylori (40195) TEST SYSTEM, ASSAY OR ANALYTE: Alpha-Fetoprotein—Tumor SmithKline FlexSure HP Test (58321) EXAMINATION: Marker (0424) ANALYTE: Hemopexin (2517) Behring Nephelometer II (07563) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR ANALYTE: Mumps Antibodies (4007) EXAMINATION: EXAMINATION: TEST SYSTEM, ASSAY OR Boehringer Mannheim ES 300 AL (07524) Behring Nephelometer II (07563) EXAMINATION: ANALYTE: Anti-Nuclear Antibodies (ANA) ANALYTE: Hepatitis A Virus Antibody Vitek Systems Vidas (67038) (0441) (2519) ANALYTE: Mycoplasma pneumoniae TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR Antibodies (4016) EXAMINATION: EXAMINATION: TEST SYSTEM, ASSAY OR Bio-Rad Radias System (07493) Abbott IMX (04056) EXAMINATION: J & S Medical Accutex SLE Latex Test ANALYTE: Immunoglobulins IgA (2803) Meridian Diagnostics ImmunoCard (31002) TEST SYSTEM, ASSAY OR Mycoplasma (40196) ANALYTE: Anti-Streptolysin O (ASO) (0452) EXAMINATION: Murex Mycoplasma pneumoniae Antibody TEST SYSTEM, ASSAY OR Beckman Synchron CX 5 CE (07491) Detection Kit (40175) EXAMINATION: Behring Nephelometer II (07563) ANALYTE: Rheumatoid Factor (RF) (5508) Beckman Synchron CX 5 CE (07491) Boehringer Mannheim Hitachi 914 (07546) TEST SYSTEM, ASSAY OR Behring Nephelometer II (07563) Du Pont ACA Star (13357) EXAMINATION: 25960 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

Behring Nephelometer II (07563) Helena Laboratories Cascade M (25156) Organon Teknika AuraTek FDP (46153) Immunostics immuno/undiluted ra Test HemoTec Automated Coagulation Timer II Vitek FDP Slidex direct (67084) (28275) (25180) ANALYTE: Fibrinogen (1905) J & S Medical Accutex Rheumatoid Factor Instrumentation Laboratory MCL 2 TEST SYSTEM, ASSAY OR (RF) Latex Test (31005) Coagulation Analyzer (28297) EXAMINATION: J & S Medical Eye Spot Rheumatoid Factor International Technidyne Factor VI American Bioproducts STA Analyzer (RF) Test (31012) Premier (28296) (04594) Pulse Scientific Rheumatoid Factor (RF) International Technidyne Factor VI Behring Nephelometer II (07563) Test (49101) Premier SingleShot APTT (28293) Du Pont ACA Star (13357) Trinity Laboratories RHEUMA–LEX International Technidyne Factor VI Helena Laboratories Cascade M (25156) System (61116) Premier Vacu-APTT (28295) Instrumentation Laboratory MCL 2 ANALYTE: Rickettsia typhi Ab (Typhus International Technidyne Factor VI Coagulation Analyzer (28297) Antibodies) (5514) SingleShot APTT (28292) International Technidyne Factor VI (28093) TEST SYSTEM, ASSAY OR International Technidyne Factor VI Vacu- International Technidyne Factor VI EXAMINATION: APTT (28294) Premier (28296) Integrated Diagnostics INDX DIP–S–TICKS International Technidyne Hemochron 400 International Technidyne Hemochron 400 R. typhi (28265) Cit. One-Step APTT (28287) (28094) ANALYTE: Rubella Antibodies (5510) International Technidyne Hemochron 400 International Technidyne Hemochron 401 TEST SYSTEM, ASSAY OR Direct Draw APTT (28282) (28095) EXAMINATION: International Technidyne Hemochron 401 International Technidyne Hemochron 800 PB Diagnostics Systems OPUS Magnum Cit. One-Step APTT (28288) (28096) (49097) International Technidyne Hemochron 401 International Technidyne Hemochron 8000 PB Diagnostics Systems OPUS PLUS Direct Draw APTT (28283) (28298) (49098) International Technidyne Hemochron 800 International Technidyne Hemochron 801 Princeton BioMeditech BioSign Rubella Cit. One-Step APTT (28289) (28097) (49121) International Technidyne Hemochron 800 Medical Laboratory MLA Electra 1600C Wampole IMPACT Rubella Slide Test Direct Draw APTT (28284) (40167) (70165) International Technidyne Hemochron 8000 TOA Medical Electronics CA–1000 (61132) ANALYTE: Rubeola Antibodies (measles) (28298) TOA Medical Electronics CA–5000 (61135) (5511) International Technidyne Hemochron 8000 Vitek HEMOLAB (67075) TEST SYSTEM, ASSAY OR Cit. One-Step APTT (28291) ANALYTE: Hematocrit (2514) EXAMINATION: International Technidyne Hemochron 8000 TEST SYSTEM, ASSAY OR Vitek Systems Vidas (67038) Direct Draw APTT (28286) EXAMINATION: International Technidyne Hemochron 801 ANALYTE: Toxoplasma gondii Antibodies Abbott Cell-Dyn 1700 (04607) Cit. One-Step APTT (28290) (6113) Abbott EnCounter (04525) International Technidyne Hemochron 801 TEST SYSTEM, ASSAY OR Alicia Diagnostic Genesis I (04536) Direct Draw APTT (28285) EXAMINATION: Coulter ONYX (10254) International Technidyne Microsample Beckman Synchron CX 5 CE (07491) Coulter ONYX with Autoloader (10281) Biokit Toxogen (07494) Coagulation Analyzer (28267) DMA H12 (13284) PB Diagnostics Systems OPUS (49001) Medical Laboratory MLA Electra 1600C Danam Datacell 16CP (13363) PB Diagnostics Systems OPUS Magnum (40167) Diametrics Medical IRMA Blood Analysis (49097) Organon Teknika Multi Channel Discrete System (13362) PB Diagnostics Systems OPUS PLUS Analyzer (MDA–180) (46144) I-STAT i-STAT 200 System (28344) (49098) TOA Medical Electronics CA–1000 (61132) Infolab I–1600 (28379) Vitek Systems Vidas Toxo Competition TOA Medical Electronics CA–5000 (61135) Instrumentation Laboratory BGElectrolytes (TXC) Assay (67080) Vitek HEMOLAB (67075) (28063) ANALTYE: Varicella-Zoster Virus Antibodies ANALYTE: Antithrombin III (ATIII) (0456) Nova 16 (43103) (6704) TEST SYSTEM, ASSAY OR Nova Stat Profile 9 (43086) TEST SYSTEM, ASSAY OR EXAMINATION: Nova Stat Profile Plus 10 (43063) EXAMINATION: Behring Nephelometer II (07563) Nova Stat Profile Ultra 11P Analyzer Vitek Systems Vidas (67038) Du Pont ACA Star (13357) (43101) Separation Technology STI HemataSTAT SPECIALITY/SUBSPECIALITY: Hematology ANALYTE: Body Fluid Microscopic Elements (0716) Model C70B (58310) ANALYTE: Activated Clotting Time (ACT) TEST SYSTEM, ASSAY OR Sysmex K–4500 (58358) (0461) EXAMINATION: Sysmex K–800 (58307) TEST SYSTEM, ASSAY OR IRIS IRIScope Body Fld. Cell Count Sys. Sysmex SE–9000 (58318) EXAMINATION: (RBC/WBC enum. only) (28333) Technalysis CELLEXIS Hematology HemoTec Automated Coagulation Timer Analyzer (61102) High Range Heparinase (25184) ANALYTE: Capillary fragility (1093) Technicon H.3 RTC System (61103) HemoTec Automated Coagulation Timer II TEST SYSTEM, ASSAY OR Technicon H. 3 RTX System (61104) (25180) EXAMINATION: Texas International Laboratories H12 HemoTec Automated Coagulation Timer II Capillary Fragility/Tourniquet Test (10247) (61128) High Range Heparinase (25185) ANALYTE: Fibrin Monomers (1927) ANALYTE: Hemoglobin (2515) International Technidyne Hemochron 8000 TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR (28298) EXAMINATION: EXAMINATION: International Technidyne Hemochron Jr. Ethanol Gel; Protamine Sulfate (no serial AVL 995 Hb (04021) Microcoagulation (28345) dilutions) (16044) Abbott Cell-Dyn 1700 (04607) ANALYTE: Activated Partial Thromboplastin ANALYTE: Fibrin Split Products (Fibrin Abbott EnCounter (04525) Time (APTT) (0409) Degradation) (1904) Alicia Diagnostics Genesis I (04536) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR Artel HbM Hemoglobinometer (04551) EXAMINATION: EXAMINATION: Ciba Corning 280 (10036) American Bioproducts STA Analyzer Baxter Diagnostic Dimertest Latex Assay Ciba Corning 288 (10037) (04594) (07552) Ciba Corning 845 (10296) Behring Fibrintimer A (07516) Baxter Diagnostic FDP Detection Set Ciba Corning 855 (10297) Cardiovascular Diagnostics TAS Analyzer (07551) Ciba Corning 865 (10298) (10257) Du Pont ACA Star (13357) Coulter ONYX (10254) Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25961

Coulter ONYX with Autoloader (10281) Behring Fibrintimer A (07516) International Technidyne Hemochron 400 DMA H12 (13284) Boehringer Mannheim CoaguChek System HiTT (28304) Danam Datacell 16CP (13363) (07496) International Technidyne Hemochron 401 I-STAT i-STAT 200 System (28344) Cardiovascular Diagnostics TAS Analyzer HNTT (28300) Infolab I–1600 (28379) (10257) International Technidyne Hemochron 401 Radiometer ABL 1 (55049) Helena Laboratories Cascade M (25156) HiTT (28305) Radiometer ABL 2 (55001) HemoTec Automated Coagulation Timer II International Technidyne Hemochron 800 Radiometer ABL 2 RA (55050) (25180) HNTT (28301) Radiometer ABL 3 (55002) Instrumentation Laboratory MCL 2 International Technidyne Hemochron 800 Radiometer ABL 3 M (55051) Coagulation Analyzer (28297) HiTT (28306) Radiometer ABL 300 (55004) International Technidyne Factor VI Jr. International Technidyne Hemochron 8000 Radiometer ABL 4 (55006) Microcoagulation (28346) (28298) Radiometer ABL 510 (55054) International Technidyne Factor VI International Technidyne Hemochron 8000 Radiometer ABL 520 (55055) Premier (28296) HNTT (28303) Separation Technology STI HemataSTAT International Technidyne Hemochron 8000 International Technidyne Hemochron 8000 Model C70B (58310) (28298) HiTT (28308) StatChem StatTest System (58269) International Technidyne Hemocrhon Jr. International Technidyne Hemochron 801 Sysmex K–4500 (58358) Microcoagulation (28345) HNTT (28302) Sysmex K–800 (58307) Medical Laboratory MLA Electra 1600C International Technidyne Hemochron 801 Sysmex SE–9000 (58318) (40167) HiTT (28307) Technalysis CELLEXIS Hematology Organon Teknika Multi Channel Discrete Medical Laboratory MLA Electra 1600C Analyzer (61102) Analyzer (MDA–180) (46144) (40167) Technicon H.3 RTC System (61103) TOA Medical Electronics CA–1000 (61132) TOA Medical Electronics CA–1000 (61132) Technicon H.3 RTX System (61104) TOA Medical Electronics CA–5000 (61135) TOA Medical Electronics CA–5000 (61135) Texas International Laboratories H12 Vitek HEMOLAB (67075) Vitek HEMOLAB (67075) (61128) ANALYTE: Red Blood Cell Count ANALYTE: White Blood Cell Count ANALYTE: Heparin (2518) (Erythrocyte Count) (RBC) (5502) (Leukocyte Count) (WBC) (7002) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR EXAMINATION: EXAMINATION: EXAMINATION: Du Pont ACA Star (13357) Abbott Cell-Dyn 1700 (04607) Abbott Cell-Dyn 1700 (04607) ANALYTE: Heparin Dose Response (HDR) Abbott EnCounter (04525) Abbott EnCounter (04525) (2539) Alicia Diagnostics Genesis I (04536) Alicia Diagnostics Genesis I (04536) TEST SYSTEM, ASSAY OR Coulter ONYX (10254) Coulter ONYX (10254) EXAMINATION: Coulter ONYX with Autoloader (10281) Coulter ONYX with Autoloader (10281) International Technidyne Factor VI (28093) DMA H12 (13284) DMA H12 (13284) International Technidyne Hemochron 400 Danam Datacell 16CP (13363) Danam Datacell 16CP (13363) (28094) Infolab I–1600 (28379) Infolab I–1600 (28379) International Technidyne Hemochron 401 Sysmex K–4500 (58358) Sysmex K–4500 (58358) (28095) Sysmex K–800 (58307) Sysmex K–800 (58307) International Technidyne Hemochron 800 Sysmex SE–9000 (58318) Sysmex SE–9000 (58318) (28096) Technalysis CELLEXIS Hematology Technalysis CELLEXIS Hematology International Technidyne Hemochron 8000 Analyzer (61102) Analyzer (61102) (28298) Technicon H.3 RTC System (61103) Technicon H.3 RTC System (61103) International Technidyne Hemochron 801 Technicon H.3 RTX System (61104) Technicon H.3 RTX (61104) (28097) Texas International Laboratories H12 Texas International Laboratories H12 ANALYTE: Plasminogen (4907) (61128) (61128) ANALYTE: Reticulocyte Count (5506) ANALYTE: White Blood Cell Differential TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR (WBC Diff) (7001) EXAMINATION: EXAMINATION: TEST SYSTEM, ASSAY OR Behring Nephelometer II (07563) Becton Dickinson FACSCAN (with retic EXAMINATION: Du Pont ACA Star (13357) count software) (07518) Abbott Cell-Dyn 1700 (04607) ANALYTE: Platelet Count (4908) Coulter MAXM (10078) Abbott EnCounter (04525) TEST SYSTEM, ASSAY OR Coulter STKS (10093) Alicia Diagnostics Genesis I (04536) EXAMINATION: Technicon H.3 RTC System (61103) Coulter ONYX (10254) Abbott Cell-Dyn 1700 (04607) Technicon H.3 RTX System (61104) Coulter ONYX with Autoloader (10281) Abbott EnCounter (04525) ANALYTE: Semen (5822) DMA H12 (13284) Alicia Diagnostics Genesis I (04536) TEST SYSTEM, ASSAY OR Danam Datacell 16CP (13363) Coulter ONYX (10254) EXAMINATION: Infolab I–1600 (28379) Coulter ONYX with Autoloader (10281) IRIS IRIScope Body Fld. Cell Count Sys. Sysmex K–4500 (58358) DMA H12 (13284) (sperm enum. only) (28334) Sysmex SE–9000 (58318) Danam Datacell 16CP (13363) ANALYTE: Thrombin Time (6105) Technalysis CELLEXIS Hematology Infolab I–1600 (28379) TEST SYSTEM, ASSAY OR Analyzer (61102) Sysmex K–4500 (58358) EXAMINATION: Technicon H.3 RTC System (61103) Sysmex K–800 (58307) American Bioproducts STA Analyzer Technicon H.3 RTX System (61104) Sysmex SE–9000 (58318) (04594) Texas International Laboratories H12 Technalysis CELLEXIS Hematology Helena Laboratories Cascade M (25156) (61128) Analyzer (61102) Instrumentation Laboratory MCL 2 SPECIALITY/SUBSPECIALITY: Mycology Technicon H.3 RTC System (61103) Coagulation Analyzer (28297) Technicon H.3 RTX System (61104) International Technidyne Factor VI ANALYTE: Dermatophytes (1302) Texas International Laboratories H12 Premier (28296) TEST SYSTEM, ASSAY OR (61128) International Technidyne Factor VI EXAMINATION: ANALYTE: Prothrombin Time (PT) (4922) Preimer Throm. Time Plus (28310) Biomed Diagnostics InTray DM Medium TEST SYSTEM, ASSAY OR International Technidyne Factor VI (07559) EXAMINATION: Thrombin Time Plus (28309) Troy Biologicals Dermatophyte Test American Bioproducts STA Analyzer International Technidyne Hemochron 400 Medium (61106) (04594) HNTT (28299) ANALYTE: Yeast, Candida only (7603) 25962 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

TEST SYSTEM, ASSAY OR Drug Screening Systems microLINE Schiapparelli Biosystems ACE Clinical EXAMINATION: Screens (13259) Chemistry System (58288) MicroProbe Affirm VPIII Microbial Du Pont ACA Star (13357) ANALYTE: Digitoxin (1303) Identification Test (40163) Olympus AU 5041 (46145) TEST SYSTEM, ASSAY OR SPECIALITY/SUBSPECIALITY: Parasitology Olympus AU 5121 (46087) EXAMINATION: Olympus AU 5200 (46143) ANALYTE: Cryptosprodium (1109) Cirrus Diagnostics Immulite (10159) TEST SYSTEM, ASSAY OR ANALYTE: Cannabinoids (THC) (1009) Du Pont ACA Star (13357) EXAMINATION: TEST SYSTEM, ASSAY OR ANALYTE: Digoxin (1304) Alexon ProSpecT Cryptosporidum Rapid EXAMINATION: TEST SYSTEM, ASSAY OR Assay (dir. Ag/vis.) (04553) Beckman Synchron CX 5 CE (07491) EXAMINATION: ANALYTE: Giardia lamblia (2222) Biosite Triage Panel Drugs of Abuse plus Abbott AxSYM (04532) TEST SYSTEM, ASSAY OR Tricyl.Antidprsnt. (07528) Beckman Synchron CX 4 CE (07174) EXAMINATION: Boehringer Mannheim Hitachi 914 (07546) Beckman Synchron CX 5 CE (07491) Alexon ProSpecT Giardia Rapid Assay Du Pont ACA Star (13357) Boehringer Mannheim ES 300 AL (07524) (direct antigen/visual) (04364) Olympus AU 5041 (46145) Boehringer Mannheim Hitachi 914 (07546) Olympus AU 5121 (46087) Du Pont ACA Star (13357) ANALYTE: Scabies (5831) Olympus AU 5200 (46143) Du Pont Dimension XL (13355) TEST SYSTEM, ASSAY OR Princeton BioMeditech AbuSign DOA 4 Kodak Ektachem 250 (34037) EXAMINATION: (49130) Kodak Ektachem 950 IRC (34087) All Direct Wet Mount Preparations (04108) Princeton BioMeditech AbuSign THC PB Diagnostics Systems OPUS Magnum ANALYTE: Trichomonas (6116) (49133) (49097) TEST SYSTEM, ASSAY OR Princeton BioMeditech AccuSign THC PB Diagnostics Systems OPUS PLUS EXAMINATION: (49139) (49098) MicroProbe Affirm VPIII Microbial Princeton BioMeditech BioSign THC Sanofi Pasteur Access Immunoassay Identification Test (40163) (49137) System (58257) SPECIALITY/SUBSPECIALITY: Toxicology/ Princeton BioMeditech DOA–COC (49135) Schiapparelli Biosystems ACE Clinical TDM Roche OnTrak TESTCUP Collection/ Chemistry System (58288) ANALYTE: Acetaminophen (0406) Urinalysis Panel (55146) Technicon OPERA Clinical Chemistry TEST SYSTEM, ASSAY OR ANALYTE: Carbamazepine (1010) System (61161) EXAMINATION: TEST SYSTEM, ASSAY OR Vitek Systems Vidas (67038) Du Pont ACA Star (13357) EXAMINATION: Wako Diagnostics 30R (70002) GDS Diagnostics Stat-Site Meter (22126) Abbott AxSYM (04532) ANALYTE: Ethanol (Alcohol) (1608) ANALYTE: Amikacin (0425) Boehringer Mannheim Hitachi 914 (07546) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR Du Pont ACA Star (13357) EXAMINATION: EXAMINATION: Instrumentation Laboratory ILAB 1800 Beckman Synchron CX 5 CE (07491) Du Pont ACA Star (13357) (28323) Boehringer Mannheim Hitachi 914 (07546) Instrumentation Laboratory ILAB 1800 Du Pont ACA Star (13357) ANALYTE: Amphetamines (0428) Du Pont Dimension XL (13355) TEST SYSTEM, ASSAY OR (28322) PB Diagnostics Systems OPUS Magnum Kodak Ektachem 950 IRC (34087) EXAMINATION: Olympus AU 5041 (46145) Beckman Synchron CX 5 CE (07491) (49097) Biosite Triage Panel Drugs of Abuse plus PB Diagnostics Systems OPUS Magnum ANALYTE: Ethosuximide (1609) Tricyl.Antidprsnt. (07528) (49098) TEST SYSTEM, ASSAY OR Boehringer Mannheim Hitachi 911 (07377) Seradyn LPIA–100 (58294) EXAMINATION: Boehringer Mannheim Hitachi 914 (07546) ANALYTE: Carboxyhemoglobin (1012) Du Pont ACA Star (13357) Drug Screening Systems microLINE TEST SYSTEM, ASSAY OR ANALYTE: Gentamicin (2202) Screens (13259) EXAMINATION: TEST SYSTEM, ASSAY OR Du Pont ACA Star (13357) Ciba Corning 845 (10296) EXAMINATION: Olympus AU 5041 (46145) Ciba Corning 855 (10297) Abbott AxSYM (04532) Olympus AU 5121 (46087) Ciba Corning 865 (10298) Beckman Synchron CX 5 CE (07491) Olympus AU 5200 (46143) Radiometer ABL 620 (55137) Boehringer Mannheim Hitachi 914 (07546) Princeton BioMeditech AbuSign DOA 4 ANALYTE: Cocaine Metabolites (1023) Du Pont ACA Star (13357) (49130) TEST SYSTEM, ASSAY OR Instrumentation Laboratory ILAB 1800 ANALYTE: Barbiturates (0701) EXAMINATION: (28323) TEST SYSTEM, ASSAY OR Beckman Synchron CX 5 CE (07491) Instrumentation Laboratory ILAB 900 (28322) EXAMINATION: Biosite Triage Panel Drugs of Abuse plus PB Diagnostics Systems OPUS Magnum Beckman Synchron CX 5 CE (07491) Tricyl.Antidprsnt. (07528) (49097) Biosite Triage Panel Drugs of Abuse plus Boehringer Mannheim Hitachi 911 (07377) PB Diagnostics Systems OPUS PLUS Tricyl.Antidprsnt. (07528) Boehringer Mannheim Hitachi 914 (07546) (49098) Boehringer Mannheim Hitachi 914 (07546) Du Pont ACA Star (13357) Seradyn LPIA–100 (58294) Drug Screening Systems microLINE EDITEK VERDICT COCAINE (16078) Technicon OPERA Clinical Chemistry Screens (13259) Olympus AU 5041 (46145) System (61161) Du Pont ACA Star (13357) Olympus AU 5121 (46087) Olympus AU 5041 (46145) Olympus AU 5200 (46143) ANALYTE: Isonicotinic Acid (2819) Olympus AU 5121 (46087) Princeton BioMeditech AbuSign COC TEST SYSTEM, ASSAY OR Olympus AU 5200 (46143) (49132) EXAMINATION: Schiapparelli Biosystems ACE Clinical Princeton BioMeditech AbuSign DOA 4 DynaGen MYCODYN URITEC Test Strips Chemistry System (58288) (49130) (13264) ANALYTE: Benzodiazepines (0702) Princeton BioMeditech AccuSign COC ANALYTE: Lidocaine (3710) TEST SYSTEM, ASSAY OR (49138) TEST SYSTEM, ASSAY OR EXAMINATION: Princeton BioMeditech BioSign COC EXAMINATION: Beckman Synchron CX 5 CE (07491) (49136) Du Pont ACA Star (13357) Biosite Triage Panel Drugs of Abuse plus Princeton BioMeditech DOA–TCO (49134) ANALYTE: Lithium (3712) Tricyl.Antidprsnt. (07528) Roche OnTrak TESTCUP Collection/ TEST SYSTEM, ASSAY OR Boehringer Mannheim Hitachi 914 (07546) Urinalysis Panel (55146) EXAMINATION: Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25963

Instrumentation Laboratory ILyte Na, K, Li Beckman Synchron CX 5 CE (07491) Technicon OPERA Clinical Chemistry System (28319) Biosite Triage Panel Drugs of Abuse plus System (61161) Ionetics Model 400/450 Electrolyte Tricyl.Antidpresnt. (07528) ANALYTE: Primidone (4912) Analyzer (28324) Boehringer Mannheim Hitachi 911 (07377) TEST SYSTEM, ASSAY OR Kodak Ektachem 250 (34037) Boehringer Mannheim Hitachi 914 (07546) EXAMINATION Kodak Ektachem 400 (34012) Du Pont ACA Star (13357) Boehringer Mannheim Hitachi 914 (07546) Kodak Ektachem 500 (34013) EDITEK VERDICT OPIATES (16077) Du Pont ACA Star (13357) Kodak Ektachem 550 XRC Analyzer Olympus AU 5041 (46145) ANALYTE: Procainamide (4913) (34056) Olumpus AU 5121 (46087) TEST SYSTEM, ASSAY OR Kodak Ektachem 700 (34014) Olympus AU 5200 (46143) EXAMINATION: Kodak Ektachem 700 Analyzer C Series Princeton BioMeditech AbuSign DOA 4 Du Pont ACA Star (13357) (34054) (49130) PB Diagnostics System OPUS (49001) Kodak Ektachem 700 P (34024) Princeton BioMeditech AbuSign Opi Kodak Ektachem 700 XR (34015) (49144) ANALYTE: Propoxyphene (4917) Kodak Ektachem 750 XRC Analyzer Princeton BioMeditech AccuSign Opi TEST SYSTEM, ASSAY OR (34055) (49146) EXAMINATION: Kodak Ektachem 950 IRC (34087) Princeton BioMeditech BioSign Opi Olympus AU 5041 (46145) Kodak Ektachem DT 60 (34016) (49147) Olympus AU 5121 (46087) Kodak Ektachem DT II (34057) Princeton BioMeditech DOA-Opi (49145) Olympus AU 5200 (46143) Kodak Ektachem DT SC II Module (34028) ANALYTE: Phencyclidine (PCP) (4901) ANALYTE: Quinidine (5202) Kodak Ektachem DT SC Module (34017) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR Kodak Ektachem DTE Module (34018) EXAMINATION: EXAMINATION: Nova 10 (with CRT) (43061) Beckman Synchron CX 5 CE (07491) Abbott AxSYM (04532) ANALYTE: Methadone (4003) Biosite Triage Panel Drugs of Abuse plus Boehringer Mannheim Hitachi 914 (07546) TEST SYSTEM, ASSAY OR Tricyl.Antidprsnt. (07528) Du Pont ACA Star (13357) EXAMINATION: Boehringer Mannheim Hitachi 914 (07546) ANALYTE: Salicylates (5801) Beckman Synchron CX 5 CE (07491) Du Pont ACA Star (13357) TEST SYSTEM, ASSAY OR Biosite Triage Panel for Drugs of Abuse EDITEK EZ-Screen:PCP (16073) EXAMINATION: (07195) Olympus AU 5041 (46145) Beckman Synchron CX 5 CE (07491) Boehringer Mannheim Hitachi 914 (07546) Olympus AU 5121 (46087) Boehringer Mannheim Hitachi 914 (07546) Du Pont ACA (13082) Olympus AU 5200 (46143) Du Pont ACA Star (13357) Du Pont ACA II (13172) Schiapparelli Biosystems ACE Clinical Du Pont Dimension XL (13355) Du Pont ACA III (13173) Chemistry System (58288) Kodak Ektachem 550 XRC Analyzer Du Pont ACA IV (13083) ANALYTE: Phenobarbital (4902) (34056) Du Pont ACA Star (13357) Kodak Ektachem 700 Analyzer C Series Du Pont ACA V (13084) TEST SYSTEM, ASSAY OR EXAMINATION: (34054) Olympus AU 5041 (46145) Kodak Ektachem 750 XRC Analyzer Olympus AU 5121 (46087) Abbott AxSYM (04532) Baxter Paramax (07048) (34055) Olympus AU 5200 (46143) Kodak Ektachem 950 (IRC (34087) Roche Abuscreen ONTRAK (55099) Baxter Paramax 720 (07186) Baxter Paramax 720 ZX (07049) ANALYTE: Theophylline (6104) ANALYTE: Methamphetamines (4004) Beckman Synchron CX 5 CE (07491) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR Boehringer Mannheim Hitachi 914 (07546) EXAMINATION: EXAMINATION: Du Pont ACA Star (13357) Abbott AxSYM (04532) Biosite Triage Panel Drugs of Abuse plus Du Pont Dimension XL (13355) Baxter Paramax (07048) Tricyl.Antidprsnt. (07528) Instrumentation Laboratory ILAB 1800 Baxter Paramax 720 (07186) ANALYTE: Methaqualone (4005) (28323) Baxter Paramax 720 ZX (07049) TEST SYSTEM, ASSAY OR Instrumentation Laboratory ILAB 900 Beckman Synchron CX 5 CE (07491) EXAMINATION: (28322) Boehringer Mannheim Hitachi 914 (07546) Boehringer Mannheim Hitachi 914 (07546) PB Diagnostics Systems OPUS Magnum Du Pont ACA Star (13357) Olympus AU 5041 (46145) (49097) Du Pont Dimension XL (13355) Olympus AU 5121 (46087) PB Diagnostics Systems OPUS PLUS Immunomatrix Theophylline Blood Olympus AU 5200 (46143) (49098) Monitoring System (28318) ANALYTE: Methotrexate (4006) Schiapparelli Biosystems ACE Clinical Instrumentation Laboratory ILAB 1800 TEST SYSTEM, ASSAY OR Chemistry System (58288) (28323) EXAMINATION: Seradyn LPIA–100 (58294) Instrumentation Laboratory ILAB 900 Du Pont ACA Star (13357) Technicon OPERA Clinical Chemistry (28322) ANALYTE: Morphine (4020) System (61161) Kodak Ektachem 550 XRC Analyzer TEST SYSTEM, ASSAY OR ANALYTE: Phenytoin (4903) (34056) EXAMINATION: TEST SYSTEM, ASSAY OR Kodak Ektachem 700 Analyzer C Series Roche OnTrak TESTCUP Collection/ EXAMINATION: (34054) Urinalysis Panel (55146) Abbott AxSYM (04532) Kodak Ektachem 750 XRC Analyzer Sun Biomedical Labs Visualine II Baxter Paramax (07048) (34055) Morphine/Opiates/Heroin (58359) Baxter Paramax 720 (07186) Kodak Ektachem 950 IRC (34087) ANALYTE: N-Acetylprocainamide (NAPA) Baxter Paramax 720 ZX (07049) Kodak Ektachem DT II (34057) (4301) Beckman Synchron CX 5 CE (07491) PB Diagnostics Systems OPUS Magnum TEST SYSTEM, ASSAY OR Boehringer Mannheim Hitachi 914 (07546) (49097) EXAMINATION: Du Pont ACA Star (13357) PB Diagnostics Systems OPUS PLUS Du Pont ACA Star (13357) Du Pont Dimension XL (13355) (49098) PB Diagnostics Systems OPUS (49001) Kodak Ektachem 250 (34037) Schiapparelli Biosystems ACE Clinical PB Diagnostics Systems OPUS Magnum Kodak Ektachem 950 IRC (34087) Chemistry System (58288) (49097) PB Diagnostics Systems OPUS Magnum Technicon OPERA Clinical Chemistry PB Diagnostics Systems OPUS PLUS (49097) System (61161) (49098) PB Diagnostics Systems OPUS PLUS Vitek Systems Vidas (67038) ANALYTE: Opiates (4601) (49098) ANALYTE: Tobramycin (6112) TEST SYSTEM, ASSAY OR Schiapparelli Biosystems ACE Clinical TEST SYSTEM, ASSAY OR EXAMINATION: Chemistry System (58288) EXAMINATION: 25964 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

Abbott AxSYM (04532) Orion Diagnostica Diarlex Rota-Adeno (dir. Sanofi Pasteur Chlamydia Micro. EIA Beckman Synchron CX 5 CE (07491) antigen/visual) (46154) Blocking (dir.ag/spec.) (58330) Boehringer Mannheim Hitachi 911 (07377) ANALYTE: Rotavirus (5509) Sanofi Pasteur Chlamydia Microplate EIA Boehringer Mannheim Hitachi 914 (07546) TEST SYSTEM, ASSAY OR (dir. ag./spectro.) (58336) Du Pont ACA Star (13357) EXAMINATION: Syva MicroTrak II Chlamydia EIA Blocking PB Diagnostics Systems OPUS Magnum Abbott TestPack Rotavirus (direct antigen/ Assay (dir.ag/spec) (58335) (49097) visual) (04516) ANALYTE: Clostridium difficile (1022) PB Diagnostics Systems OPUS PLUS Meridian Diagnostics ImmunoCard TEST SYSTEM, ASSAY OR (49098) Rotavirus (40189) EXAMINATION: Technicon OPERA Clinical Chemistry Orion Diagnostica Diarlex Rota-Adeno (dir. Alexon ProSpecT Clostridium difficile System (61161) antigen/visual) (46154) (direct Ag/spectro) (04540) ANALYTE: Tricyclic Antidepressants (6117) COMPLEXITY: High Alexon ProSpecT Clostridium difficile TEST SYSTEM, ASSAY OR (direct Ag/visual) (04539) EXAMINATION: SPECIALITY/SUBSPECIALITY: Bacteriology Becton Dickinson CULTURETTE BRAND Biosite Triage Panel Drugs of Abuse plus ANALYTE: Aerobic &/or Anaerobic Toxin CD (dir. Ag/visual) (07486) Tricyl.Antidprsnt. (07528) Organisms-unlimited sources (0412) Becton Dickinson CULTURETTE BRAND Du Pont ACA Star (13357) TEST SYSTEM, ASSAY OR Toxin CD (dir. Ag/Spectro) (07487) ANALYTE: Valproic Acid (6701) EXAMINATION: TechLab C. difficile 1-hour TOX–A Test TEST SYSTEM, ASSAY OR Alamar Bacterial Identification Panel (spectrophotometric) (61149) EXAMINATION: (including culture) (04531) TechLab C. difficile 1-hour TOX–A Test Abbott AxSYM (04532) Analytab API 20E/UniScept 20E (including (visual) (61148) Boehringer Mannheim Hitachi 704 (07161) culture) (04513) TechLab C. difficile Toxin/Antitoxin Kit Boehringer Mannheim Hitachi 717 (07163) Becton Dickinson Crystal E/NF ID System (61107) Boehringer Mannheim Hitachi 911 (07377) (including culture) (07485) TechLab Clostridium difficile TOX–B Test Boehringer Mannheim Hitachi 914 (07546) Becton Dickinson Crystal RS/E ID System (61147) Ciba Corning Biotrack 516 (10048) (including culture) (07484) ANALYTE: Dental plaque (1317) Du Pont ACA Star (13357) Micro Media Sys. Microdilution MIC/ID TEST SYSTEM, ASSAY OR PB Diagnostics Systems OPUS Magnum Panels (inc. culture) (40201) EXAMINATION: (49097) Radiometer Microbat 12A & 12A∂12B G/ BioScan Video Phase Contrast Microscope PB Diagnostics Systems OPUS PLUS neg ID Sys (inc. cult.) (55115) (07499) (49098) Roche Oxi/Ferm II (including culture) ANALYTE: Escherichia coli (1604) Seradyn LPIA–100 (58294) (55116) TEST SYSTEM, ASSAY OR Vitek Systems Rapid NFT (including ANALYTE: Vancomycin (6703) EXAMINATION: culture) (67076) TEST SYSTEM, ASSAY OR Remel E. coli 0157:H7 Latex Test EXAMINATION: ANALYTE: Aerobic Organisms from urine (including culture) (55125) Abbott AxSYM (04532) specimens only (0468) ANALYTE: Legionella (3706) Du Pont ACA Star (13357) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR PB Diagnostics Systems OPUS (49001) EXAMINATION: EXAMINATION: PB Diagnostics Systems OPUS Magnum Adams Scientific Selecticult-U Binax Legionella Urinary Antigen EIA (49097) (nonconfirmatory ID) (04548) (07527) PB Diagnostics Systems OPUS PLUS BioClinical Systems Bullseye Urine Plate (49098) (nonconfirm. ID) (07539) ANALYTE: N. gonorrhoeae (from urogenital SPECIALITY/SUBSPECIALITY: Urinalysis Culture Kits, Inc. Uri-Three or rectal only) (4317) (nonconfirmatory ID) (10262) TEST SYSTEM, ASSAY OR ANALYTE: Total Solids (Specific Gravity) Future Medical Tech. Intl. Qualture EXAMINATION: (6125) (nonconfirmatory ID) (19022) Gen-Probe PACE 2C System (22171) TEST SYSTEM, ASSAY OR Innovative Diag. Systems IDS Rapid SS/U EXAMINATION: ANALYTE: Neisseria gonorrhoeae (4302) ATAGO A300CL Clinical Refractometer (including culture) (28053) TEST SYSTEM, ASSAY OR (04575) Troy Biologicals Bacti-Star II Urine Sys. EXAMINATION: ATAGO T–2 Clinical Refractometer (nonconfirm. ID) (61142) E–Y Laboratories Gonochek–II Kit (16027) (04577) Troy Biologicals Bacti-Star Urine Plate ANALYTE: Salmonella (5802) ATAGO UG–1 Digital Urine Specific (nonconfirm. ID) (61143) TEST SYSTEM, ASSAY OR Gravity Refractometer (04576) Troy Biologicals Bacti-Urine Plate EXAMINATION: ATAGO URICON–PN Urine Specific (nonconfirmatory ID) (61144) SMI MED. Salmonella O Grouping Gravity Refractometer (04578) Troy Biologicals Uri-Check Plus (including culture) (58255) (nonconfirmatory ID) (61145) Ames Clinitek Atlas Automated Urine ANALYTE: Staphyococcus (5807) Analyzer (04527) UTI-tect Bacteriuria Diag. Test System (nonconfirmatory ID) (64028) TEST SYSTEM, ASSAY OR IRIS The Yellow IRIS Model 250 (28369) EXAMINATION: IRIS The Yellow IRIS Model 450 (28370) ANALYTE: Chlamydia (1016) Trinity Laboratories STAPH–A–LEX National Instrument Hand Protometer TEST SYSTEM, ASSAY OR System (including Culture) (61129) (43085) EXAMINATION: Unipath Staphytect–OD (including culture) ANALYTE: Urine Qualitative Dipstick DAKO IDEIA Chlamydia (direct Ag/ (64030) Chemistries (6406) spectrophoto) (13329) DAKO IDEIA Chlamydia (direct Ag/visual) ANALYTE: Streptococcus pneumoniae TEST SYSTEM, ASSAY OR (5808) EXAMINATION: (13328) DAKO IMAGEN Chlamydia (direct antigen) TEST SYSTEM, ASSAY OR Ames Clinitek Atlas Automated Urine EXAMINATION: Analyzer (04527) (13334) Gen-Probe PACE 2C System (22171) AB Biodisk Etest for S. pneumoniae Boehringer Mannheim CHEMSTRIP Mini (including culture) (04561) UA Urine Analyzer (07565) Gen-Probe Pace2 Probe Competition Assay Boehringer Mannheim Chemstrip Super (PCA) (dir. Ag) (22166) ANALYTE: Streptococcus, group A (5810) UA Urine Analyzer (07520) NeoGenex C. trachomatis Antigen Test TEST SYSTEM, ASSAY OR (direct antigen) (43099) EXAMINATION: SPECIALITY/SUBSPECIALITY: Virology NeoGenex C. trachomatis Antigen Test Becton Dickinson Precise STREP A ANALYTE: Adenovirus (0410) (inc. cell culture) (43098) (including culture) (07427) TEST SYSTEM, ASSAY OR Roche Amplicor Chlamydia Trachomatis Gen-Probe Group A Streptococcus Direct EXAMINATION: Test (55118) Test (22165) Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25965

Pro-lab Prolex Streptococcal Grouping Bioanalytical Systems Urinary SeaLite Sciences AquaLite hCG (58340) Latex (inc. culture) (49116) Catecholamine Kit (07560) Wallac Oy DELFIA hCG Kit (70147) Remel RIM Strep Grouping LA Test ANALYTE: Cortisol (1032) ANALYTE: Homovanillic Acid (HVA) (2545) (including culture) (55139) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR Syntron QuikPac Strep A (EIA) Test EXAMINATION: EXAMINATION: (including culture) (58293) Nichols Institute Chemiluminescence esa Coulochem Electrode Array System ANALYTE: Streptococcus, group B (5811) Cortisol Assay (43082) (CEAS) (16043) TEST SYSTEM, ASSAY OR Wallac Oy DELFIA Cortisol Kit (70159) ANALYTE: Human Growth Hormone (GH) EXAMINATION: elias usa Synelisa Cortisol (16048) (2547) Pacific Biotech Cards O.S. Strep B. ANALYTE: Cortisol, Urine (extraction TEST SYSTEM, ASSAY OR (including culture) (49115) procedure) (1095) EXAMINATION: Pro-Lab Prolex Streptococcal Grouping TEST SYSTEM, ASSAY OR Nichols Institute Chemiluminescence HGH Latex (inc. culture) (49116) EXAMINATION: Assay (43068) Remel RIM Strep Grouping LA Test Abbott TDX (04071) Wallac Oy DELFIA hGH Kit (70162) (including culture) (55139) Abbott TDX FLx (04072) ANALYTE: Insulin-like Grwth Factor Bind. ANALYTE: Streptococcus, group C (5812) Sanofi Pasteur Access Immunoassay Protein3 (IGFBP–3) (2832) TEST SYSTEM, ASSAY OR System (58257) TEST SYSTEM, ASSAY OR EXAMINATION: Vitek Systems Vidas (67038) EXAMINATION: Pro-Lab Prolex Streptococcal Grouping ANALYTE: Dehydroepiandrosterone (DHEA) Diagnostic Systems Active IGFBP–3 IRMA Latex (inc. culture) (49116) (1309) Kit (13375) Remel RIM Strep Grouping LA Test TEST SYSTEM, ASSAY OR Diagnostic Systems DSL–6700 IGFBP–3 (including culture) (55139) EXAMINATION: RIA Kit (13310)) ANALYTE: Streptococcus, group D (5813) Diagnositic Systems DSL–9000 Active Endocrine Sciences IGFBP–3 RIA Kit TEST SYSTEM, ASSAY OR DHEA RIA Kit (13309) (16060) EXAMINATION: Nichols Institute Chemiluminescence ANALYTE: Luteinizing Hormone (LH) (3713) Pro-Lab Prolex Streptococcal Grouping DHEA Assay (43079) TEST SYSTEM, ASSAY OR Latex (inc. culture) (49116) elias usa Synelisa DHEA Sulfate EIA Kit EXAMINATION: ANALYTE: Streptococcus, group F (5814) (16062) ICN ImmuChem LH–MW Elisa Kit (28269) TEST SYSTEM, ASSAY OR ANALYTE: Dehydroepiandrosterone Sulfate Roche Cobas Core LH EIA (manual EXAMINATION: (DHEA-SO4) (1310) procedure) (55121) Pro-Lab Prolex Streptococcal Grouping TEST SYSTEM, ASSAY OR SeaLite Sciences AquaLite LH (58339) Latex (inc. culture) (49116) EXAMINATION: Wallac Oy DELFIA hLH Kit (70150) Remel RIM Strep Grouping LA Test Nichols Institute Chemiluminescence Wallac Oy DELFIA hLH Spec Kit (70151) (including culture) (55139) DHEA-S Assay (43083) ANALYTE: Parathyroid Hormone—Intact ANALYTE: Streptococcus, group G (5815) (4924) ANALYTE: Erythropoietin (1611) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR EXAMINATION: EXAMINATION: EXAMINATION: Pro-Lab Prolex Streptococcal Grouping Bio-Rad CoTube (07138) Genzyme Predicta Erythropoietin Kit Latex (inc. culture) (49116) Diagnostic Products Corp. Coat-A-Count Remel RIM Strep Grouping LA Test (22159) (13030) (including culture) (55139) Nichols Institute Cheiluminescence Immunodiagnostic Systems ltd Gamma- Erythropoietin Assay (43100) BCT Intact PTH (28351) SPECIALITY/SUBSPECIALITY: R & D Systems Quantikine Erythropoietin Endocrinology Immunodiagnostic Systems ltd OCTEIA ELISA (55114)) Intact PTH (28350) ANALYTE: 17 OH Progesterone, Neonatal R & D Systems Quantikine IVD Nichols Institute Chemiluminescence PTH (0103) Erythropoietin ELISA (55132) Assay (43080) TEST SYSTEM, ASSAY OR ANALYTE: Estradiol (1605) ANALYTE: Progesterone (4914) EXAMINATION: TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR Wallac Oy DELFIA Neo-17a-OHP Kit EXAMINATION: EXAMINATION: (70157) Bio-Rad CoTube (07138) CyberFluor FIAgen Progesterone Assay Kit ANALYTE: 17 alpha-OH Progesterone (0109) Clinical Assays GammaCoat (10060) (10261) TEST SYSTEM, ASSAY OR Diagnostic Products Corp. Coat-a-Count Immunotech Progesterone RIA Kit (28325) EXAMINATION: Estradiol-6 (13317) Wallac Oy DELFIA Progesterone Kit Pantex NeoScreen ELISA 17 alpha- Wallac Oy DELFIA Estradiol Kit (70148) (70153) Hydroxyprogesterone (49124) ANALYTE: Estrone (1628) elias usa Synelisa Progesterone (16046) ANALYTE: 5-Hydroxyindolacetic Acid, TEST SYSTEM, ASSAY OR ANALYTE: Prolactin (4915) Urine (5-HIAA) (0101) EXAMINATION: TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR Diagnostic Systems Estrone RIA Kit EXAMINATION: EXAMINATION: (13314) Abbott RIA Bead (04061) esa Coulochem Electrode Array System ANALYTE: Follicle Stimulating Hormone Nichols Institute Chemiluminescence (CEAS) (16043) (FSH) (1908) Prolactin Assay (43069) ANALYTE: Adrenocorticotropic Hormone TEST SYSTEM, ASSAY OR Roche Cobas Core Prolactin EIA (manual (ACTH) (0458) EXAMINATION: procedure) (55122) TEST SYSTEM, ASSAY OR Nichols Institute Chemiluminescence FSH Wallac Oy DELFIA Prolactin Kit (70152) EXAMINATION: Assay (43066) ANALYTE: Renin (5515) Nichols Institute Chemiluminescence Roche Cobas Core FSH EIA (manual TEST SYSTEM, ASSAY OR ACTH Assay (43074) procedure) (55124) EXAMINATION: ANALYTE: Aldosterone (0459) SeaLite Sciences AquaLite FSH (58342) Nichols Institute BV Active Renin RIA TEST SYSTEM, ASSAY OR Wallac Oy DELFIA hFSH Kit (70149) (43062) EXAMINATION: ANALYTE: HCG, Beta, Serum, Quantitative ANALYTE: Sex Hormone Binding Globulin Diagnostic Systems DSL Active (2502) (5819) Aldosterone RIA Kit (13315) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR ANALYTE: Catecholamines, Urine (1055) EXAMINATION: EXAMINATION: TEST SYSTEM, ASSAY OR Nichols Institute Chemiluminescence HCG Wallac Oy DELFIA SHBG Kit (70154) EXAMINATION: Assay (43081) ANALYTE: Testosterone (6102) 25966 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

TEST SYSTEM, ASSAY OR Nichols Institute Chemiluminescence Free TECO Diagnostics Amylase Reagent Set EXAMINATION: T3 Assay (43078) (manual procedure) (61156) Wallac Oy DELFIA Testosterone Kit ANALYTE: Vanillylmandelic Acid (VMA) ANALYTE: Angiotensin Converting Enzyme (70155) (6710) (ACE) (0481) ANALYTE: Thyroid Stimulating Hormone TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR (TSH) (6106) EXAMINATION: EXAMINATION: TEST SYSTEM, ASSAY OR esa Coulochem Electrode Array System ALPCO Angiotensin Converting Enzyme EXAMINATION: (CEAS) (16043) REA (04562) Nichols Institute Chemiluminescence TSH SPECIALITY/SUBSPECIALITY: General ANALYTE: Anserine (0514) Assay (43065) Chemistry TEST SYSTEM, ASSAY OR Roche Cobas Core TSH EIA (manual EXAMINATION: procedure) (55129) ANALYTE: 1-Methylhistidine (0107) Beckman System 6300 Series Amino Acid STC Diagnostics TSH Micro-Plate EIA TEST SYSTEM, ASSAY OR Analyzer (07553) (58308) EXAMINATION: ANALYTE: Apolipoprotein A1 (0462) SeaLite Sciences AquaLite TSH (58350) Beckman System 6300 Series Amino Acid TEST SYSTEM, ASSAY OR Wallac Oy DELFIA hTSH Kit (70142) Analyzer (07553) EXAMINATION: ANALYTE: Thyroid Stimulating Hormone ANALYTE: 3-Methylhistidine (0108) Nichols Institute Chemiluminescence APO–A1 Assay (43077) (TSH) (Neonatal) (6107) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR EXAMINATION: ANALYTE: Apolipoprotein B (0457) EXAMINATION: Beckman System 6300 Series Amino Acid TEST SYSTEM, ASSAY OR Bioclone ELEGANCE Neonatal TSH ELISA Analyzer (07553) EXAMINATION: (computer calculate) (07555) ANALYTE: Alanine (0511) Nichols Institute Chemiluminescence APO–B Assay (43073) Bioclone ELEGANCE Neonatal TSH ELISA TEST SYSTEM, ASSAY OR (manual calculations) (07554) EXAMINATION: ANALYTE: Arginine (0515) Pantex NEOSCREEN ELISA TSH (49126) Beckman System 6300 Series Amino Acid TEST SYSTEM, ASSAY OR Wallac Oy DELFIA Neo-hTSH Kit (70156) Analyzer (07553) EXAMINATION: Beckman System 6300 Series Amino Acid ANALYTE: Alanine Aminotransferase (ALT) ANALYTE: Thyroxine (T4) (6109) Analyzer (07553) TEST SYSTEM, ASSAY OR (SGPT) (0404) ANALYTE: Asparagine (0509) EXAMINATION: TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR Abbott Tetrabead-125 (04519) EXAMINATION: EXAMINATION: Becton Dickinson SimulTRAC (07106) STC Diagnostics ALT Micro-Plate Assay (58337) Beckman System 6300 Series Amino Acid Nichols Institute Chemiluminescence Total Analyzer (07553) T4 Assay (43070) ANALYTE: Albumin (0414) ANALYTE: Aspartic Acid (0508) Roche Cobas Core T4 EIA (manual TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR procedure) (55131) EXAMINATION: EXAMINATION: Wallac Oy DELFIA T4 Kit (70145) Trace Scientific Albumin BCG Modified Beckman System 6300 Series Amino Acid Reactivity (Manual) (61118) ANALYTE: Thyroxine Binding Globulin Analyzer (07553) ANALYTE: Alkaline Phosphatase (ALP) (TBG) (6110) ANALYTE: Beta-Alanine (0732) (0416) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR EXAMINATION: EXAMINATION: EXAMINATION: Wallac Oy DELFIA TBG Kit (70146) Beckman System 6300 Series Amino Acid ANALYTE: Thyroxine, Free (FT4) (6111) Hybritech Tandem-R Ostase (25170) Analyzer (07553) Synermed Test Kit (58260) TEST SYSTEM, ASSAY OR ANALYTE: Beta-Aminoisobutyric Acid EXAMINATION: ANALYTE: Alpha-Amino-n-butyric Acid (0733) Immunotech Free T4 RIA Kit (28326) (0512) TEST SYSTEM, ASSAY OR Nichols Institute Chemiluminescence Free TEST SYSTEM, ASSAY OR EXAMINATION: T4 Assay (43071) EXAMINATION: Beckman System 6300 Series Amino Acid Roche Cobas Core FT4 EIA (manual Beckman System 6300 Series Amino Acid Analyzer (07553) Analyzer (07553) procedure) (55128) ANALYTE: Bilirubin, Direct (0704) STC Diagnostics Free T–4 Micro-Plate EIA ANALYTE: Alpha-Aminoadipic Acid (0510) TEST SYSTEM, ASSAY OR (58289) TEST SYSTEM, ASSAY OR EXAMINATION: Wallac Oy DELFIA Free T4 Kit (70143) EXAMINATION: Horizon Direct Bilirubin Manual Procedure ANALYTE: Triiodothyronine (T3) (6119) Beckman System 6300 Series Amino Acid (25151) TEST SYSTEM, ASSAY OR Analyzer (07553) Synermed Test Kit (58260) EXAMINATION: ANALYTE: Aminoethylcysteine (0513) ANALYTE: Carbon Dioxide, Total (C02) Monobind Coated Tube RIA Test System TEST SYSTEM, ASSAY OR (1003) (40164) EXAMINATION: TEST SYSTEM, ASSAY OR Nichols Institute Chemiluminescence Total Beckman System 6300 Series Amino Acid EXAMINATION: T3 Assay (43072) Analyzer (07553) Intersect Systems Test Kit (28321) Roche Cobas Core T3 EIA (manual ANALYTE: Ammonia, Plasma/Serum (0427) ANALYTE: Carnosine (1108) procedure) (55130) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR Wallac Oy DELFIA T3 Kit (70144) EXAMINATION: EXAMINATION: ANALYTE: Triiodothyronine Uptake (T3U) Bekman System 6300 Series Amino Acid Beckman System 6300 Series Amino Acid (TU) (6120) Analyzer (07553) Analyzer (07553) TEST SYSTEM, ASSAY OR ANALYTE: Amylase (0429) ANALYTE: Cholesterol (1020) EXAMINATION: TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR Nichols Institute Chemiluminescence T3 EXAMINATION: EXAMINATION: Uptake Assay (43087) Genzyme Test Kit (22164) King Diagnostics Test Kit (34051) ANALYTE: Triiodothyronine, Free (FT3) Intersect Systems Test Kit (28321) Randox Laboratories Test Kit (55106) (6121) Pointe Scientific Manual Amylase Test ANALYTE: Cholyglycine (Bile Acids) (1053) TEST SYSTEM, ASSAY OR (49103) TEST SYSTEM, ASSAY OR EXAMINATION: Synermed Test Kit (58260) EXAMINATION: Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25967

Abbott CG RIA Kit (04517) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR ANALYTE: Citrulline (1105) EXAMINATION: EXAMINATION: TEST SYSTEM, ASSAY OR Beckman System 6300 Series Amino Acid Beckman System 6300 Series Amino Acid EXAMINATION: Analyzer (07553) Analyzer (07553) Beckman System 6300 Series Amino Acid ANALYTE: Glutamic Acid (2217) ANALYTE: Hydroxyproline (2560) Analyzer (07553) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR ANALYTE: Creatine Kinase (CK) 1034) EXAMINATION: EXAMINATION: TEST SYSTEM, ASSAY OR Beckman System 6300 Series Amino Acid Beckman System 6300 Series Amino Acid EXAMINATION: Analyzer (07553) Analyzer (07553) King Diagnostics Test Kit (34051) ANALYTE: Glutamine (2218) ANALYTE: Iron (2814) Pointe Scientific Manual Creatine Kinase TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR Test (49104) EXAMINATION: EXAMINATION: Randox Laboratories CK NAC-activated Beckman System 6300 Series Amino Acid King Diagnostics Test Kit (34051) Test Kit (55117) Analyzer (07553) Sigma Diagnostics Test Kit (58051) Synermed Test Kit (58260) ANALYTE: Glycine (2219) ANALYTE: Iron Binding Capacity (post ANALYTE: Creatine Kinase Isoenzymes (CK TEST SYSTEM, ASSAY OR saturation/separation) (2815) Isoenzymes) (1052) EXAMINATION: TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR Beckman System 6300 Series Amino Acid EXAMINATION: EXAMINATION: Analyzer (07553) Abbott Spectrum CCX (04515) Helena Laboratories REP E–Z CK–30 ANALYTE: Glycosylated Hemoglobin (Hgb Beckman Synchron CX 5 CE (07491) Isoenzyme Procedure (25153) A1C) (2204) Boehringer Mannheim Hitachi 914 (07546) ANALYTE: Creatine Kinase MB Fraction TEST SYSTEM, ASSAY OR Du Pont ACA Star (13357) (CKMB) (1002) EXAMINATION: Du Pont Dimension XL (13355) TEST SYSTEM, ASSAY OR LSI ASCA Chemistry System (37069) King Diagnostics Test Kit (34051) EXAMINATION: Pointe Scientific Glycohemoglobin Test Kit Kodak Ektachem 550 XRC Analyzer CHEMROY Creatine Kinase-MB (CK–MB) (49114) (34056) Reagent Set (10280) Primus Rapid Gel Glycated Hemoglobin Kodak Ektachem 700 Analyzer C Series Diagnostic Chemicals Ltd. Assay Kit (49129) (34054) (13210) TECO Glycohemoglobin Kit (61141) Kodak Ektachem 750 XRC Analyzer Helena Laboratories Cardio REP CK ANALYTE: HDL Cholesterol (2550) (34055) Isoenzyme Procedure (25139) TEST SYSTEM, ASSAY OR Kodak Ektachem 950 IRC (34087) Helena Laboratories Cardio REP CK EXAMINATION: LSI ASCA Chemistry System (37069) Isoforms Procedure (25140) Abbott Spectrum CCX (04515) Olympus AU 5041 (46145) Pointe Scientific Creatine Kinase-MB Beckman Synchron CX 5 CE (07491) Olympus AU 5200 (46143) (manual procedure) (49117) Boehringer Mannheim Hitachi 914 (07546) ANALYTE: Iron Binding Capacity, Unsat. ANALYTE: Creatinine (1035) Du Pont ACA Star (13357) (UIBC) no pretreat. (2823) TEST SYSTEM, ASSAY OR Du Pont Dimension XL (13355) TEST SYSTEM, ASSAY OR EXAMINATION: Intersect Systems Test Kit (28321) EXAMINATION: Synermed Test Kit (58260) Olympus AU 5041 (46145) Sigma Diagnostics Test Kit (58051) ANALYTE: Cystathionine (1107) Olympus AU 5121 (46087) ANALYTE: Isoleucine (2833) TEST SYSTEM, ASSAY OR Olympus AU 5200 (46143) TEST SYSTEM, ASSAY OR EXAMINATION: Technicon OPERA Clinical Chemistry EXAMINATION: Beckman System 6300 Series Amino Acid System (61161) Beckman System 6300 Series Amino Acid Analyzer (07553) ANALYTE: Hemoglobin C (2559) Analyzer (07553) ANALYTE: Cystine (1106) TEST SYSTEM, ASSAY OR ANALYTE: Lactate Dehydrogenase (LDH) TEST SYSTEM, ASSAY OR EXAMINATION: (3701) EXAMINATION: Isolab HemoCard Hemoglobin C Assay TEST SYSTEM, ASSAY OR Beckman System 6300 Series Amino Acid (28340) EXAMINATION: Analyzer (07553) ANALYTE: Hemoglobin E (2556) HiChem LDH/L Reagent Kit (manual) ANALYTE: Ethanolamine (1629) TEST SYSTEM, ASSAY OR (25183) TEST SYSTEM, ASSAY OR EXAMINATION: ANALYTE: Lactate Dehydrogenase EXAMINATION: Isolab HemoCard Hemoglobin E (28268) Isoenzymes (3721) Beckman System 6300 Series Amino Acid ANALYTE: Hemoglobin Fractions (2544) TEST SYSTEM, ASSAY OR Analyzer (07553) TEST SYSTEM, ASSAY OR EXAMINATION: ANALYTE: Ferritin (1902) EXAMINATION: Helena Laboratories Cardio REP LD TEST SYSTEM, ASSAY OR Helena Laboratories REP Alkaline Hb-15 Isoenzyme Procedure (25169) EXAMINATION: (25144) ANALYTE: Leucine (3749) Nichols Institute Chemiluminescence ANALYTE: Hemoglobin S (2536) TEST SYSTEM, ASSAY OR Ferritin Assay (43067) TEST SYSTEM, ASSAY OR EXAMINATION: Roche Cobas Core Ferritin EIA (manual EXAMINATION: Beckman System 6300 Series Amino Acid procedure) (55123) Bio-Rad Variant (07498) Analyzer (07553) Wallac Oy DELFIA Ferritin Kit (70161) Isolab Quik-Sep Quantitative Hemoglobin ANALYTE: Lipase (3711) ANALYTE: Folate (Folic acid) (1907) S Assay (28353) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR ANALYTE: Histidine (2563) EXAMINATION: EXAMINATION: TEST SYSTEM, ASSAY OR Meditech Diagnostic System Test Kit Bio-Rad Quantaphase II (07532) EXAMINATION: (40118) ANALYTE: Gamma Glutamyl Transferase Beckman System 6300 Series Amino Acid NuClin Diagnostics ElIpAse (43090) (GGT) (2201) Analyzer (07553) Sigma Diagnostics Lipase-PS (manual TEST SYSTEM, ASSAY OR ANALYTE: Homocystine (2561) procedure) (58323) EXAMINATION: TEST SYSTEM, ASSAY OR ANALYTE: Lipoprotein Fractions (3720) King Diagnostics Test Kit (34051) EXAMINATION: TEST SYSTEM, ASSAY OR Synermed Test Kit (58260) Beckman System 6300 Series Amino Acid EXAMINATION: ANALYTE: Gamma-Aminobutyric Acid Analyzer (07553) Helena Laboratories REP Direct-Sep (2220) ANALYTE: Hydroxylysine (2562) Cholesterol (25179) 25968 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

Helena Laboratories REP HDL/LDL–30 TEST SYSTEM, ASSAY OR SPECIALITY/SUBSPECIALITY: General Electrophoresis System (25168) EXAMINATION: Immunology ANALYTE: Lysine (3750) Advanced Clinical Tech. Periocheck ANALYTE: Allergen Specific NgE (0417) TEST SYSTEM, ASSAY OR Enzyme Activity Kit (04526) TEST SYSTEM, ASSAY OR EXAMINATION: ANALYTE: Sarcosine (5835) EXAMINATION: Beckman System 6300 Series Amino Acid TEST SYSTEM, ASSAY OR Ciba Corning Magic Lite SQ Specific IgE Analyzer (07553) EXAMINATION: Immunoassay (10245) ANALYTE: Magnesium (4002) Beckman System 6300 Series Amino Acid Hycor Biomedical Specific IgE EIA– TEST SYSTEM, ASSAY OR Analyzer (07553) TURBO (25146) EXAMINATION: ANALYTE: Serine (5834) Hycor Biomedical Specific IgE RIA Isotope Horizon Diagnostics Magnesium (manual TEST SYSTEM, ASSAY OR Unit (25145) procedure) (25178) EXAMINATION: Hycor Ultra-EIA Specific IgE Assay (25166) King Diagnostics Test Kit (34051) Beckman System 6300 Series Amino Acid MAST CLA Allergy System (densitometer) ANALYTE: Methionine (4031) Analyzer (07553) (40176) TEST SYSTEM, ASSAY OR ANALYTE: Surfactant/Albumin Ratio MAST CLA–1 Chemiluminescent Allergy EXAMINATION: (5833) System (40177) Beckman System 6300 Series Amino Acid TEST SYSTEM, ASSAY OR ANALYTE: Alpha-1-Acid Glycoprotein Analyzer (07553) EXAMINATION: (orosomucoid) (0420) ANALYTE: Microalbumin (4019) Abbott TDX (04071) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR Abbott TDX FLx (04072) EXAMINATION: EXAMINATION: ANALYTE: Taurine (6141) The Binding Site BIND A RID Human Synermed IR 500 (58322) TEST SYSTEM, ASSAY OR Alpha-1 Acid Glycoprotein (61140) ANALYTE: Microprotein, CSF (4026) EXAMINATION: ANALYTE: Anti-Arbovirus Antibodies (0498) TEST SYSTEM, ASSAY OR Beckman System 6300 Series Amino Acid TEST SYSTEM, ASSAY OR EXAMINATION: Analyzer (07553) EXAMINATION: DMA Test Kit (13216) ANALYTE: Threonine (6141) Hillcrest Biologicals Arbovirus (IgG) IFA Sterling Diagnostics Test Kit (58230) TEST SYSTEM, ASSAY OR Test (25141) Hillcrest Biologicals Arbovirus (IgM) IFA ANALYTE: Microprotein, Urine (4027) EXAMINATION: Test (25142) TEST SYSTEM, ASSAY OR Beckman System 6300 Series Amino Acid EXAMINATION: Analyzer (07553) ANALYTE: Anti-Cardiolipin Antibodies DMA Test Kit (13216) ANALYTE: Transferrin (6114) (0434) Sterling Diagnostics Test Kit (58230) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR TRACE Scientific Test Kit (61044) EXAMINATION: EXAMINATION: TRACE Scientific Test Kit (61044) Hemagen Cardiolipin Antibody Kit (25150) ANALYTE: Ornithine (4606) INOVA Diagnostics QUANTA Lite ACA TEST SYSTEM, ASSAY OR ANALYTE: Triglyceride (6118) Screen (28234) EXAMINATION: TEST SYSTEM, ASSAY OR INOVA Diagnostics QUANTA Lite IgA Beckman System 6300 Series Amino Acid EXAMINATION: ACA (28233) Analyzer (07553) Randox Laboratories Test Kit (55106) Immuno Concepts Anticardiolipin Ab ANALYTE: Phenylalanine (4942) ANALYTE: Trypsin (6129) Screening Test System (28280) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR Louisville APL Diagnostics ApHL ELISA EXAMINATION: EXAMINATION: Kit (37071) Beckman System 6300 Series Amino Acid NuClin Diagnostics NuCliTryp RIA (43089) Shield Diagnostics DIASTAT Total Anti- Analyzer (07553) ANALYTE: Tryptophan (6144) Cardiolipin Kit (58295) ICN ImmuChem Phenylalanine Microwell TEST SYSTEM, ASSAY OR elias usa Synelisa Cardiolipin Abs (IgA) Enzyme Assay (28384) EXAMINATION: (16055) Porton Cambridge Quantase Phenylalanine Beckman System 6300 Series Amino Acid elias usa Synelisa Cardiolipin Abs (IgG) Assay (49125) Analyzer (07553) (16056) ANALYTE: Phosphoethanolamine (4970) ANALYTE: Tyrosine (6143) elias usa Synelisa Cardiolipin Abs (IgM) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR (16057) EXAMINATION: EXAMINATION: elias usa elias Cardiolipin (IgA) Abs EIA Beckman System 6300 Series Amino Acid Beckman System 6300 Series Amino Acid (qualitative) (16066) Analyzer (07553) Analyzer (07553) elisa usa elias Cardiolipin (IgA) Abs EIA (semiquantitative) (16067) ANALYTE: Phosphoserine (4969) ANALYTE: Urea (BUN) (6403) ANALYTE: Anti-Centromere Antibodies TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR (0487) EXAMINATION: EXAMINATION: TEST SYSTEM, ASSAY OR Beckman System 6300 Series Amino Acid AMRESCO BUN Reagent (manual EXAMINATION: Analyzer (07553) procedure) (04554) Shield Diagnostics DIASTAT Anti- ANALYTE: Proline (4971) Beckman System 6300 Series Amino Acid Centromere Kit (58312) TEST SYSTEM, ASSAY OR Analyzer (07553) elias usa Synelisa ANA Profile (16058) EXAMINATION: ANALYTE: Uric Acid (6404) elias usa Synelisa Centromere Abs (16047) Beckman System 6300 Series Amino Acid TEST SYSTEM, ASSAY OR elias usa Synelisa ENA Screen (qualitative) Analyzer (07553) EXAMINATION: (16064) ANALYTE: Protein, Glycated (4963) Randox Laboratories Test Kit (55106) elias usa Synelisa ENA Screen TEST SYSTEM, ASSAY OR Synermed Test Kit (58260) (semiquantitative) (16065) EXAMINATION: ANALYTE: Valine (6717) elias usa Varelisa Centromere Antibodies Diagnostic Specialties Protein-Bound TEST SYSTEM, ASSAY OR (qualitative) (16085) Glucose Assay Kit (13286) EXAMINATION: elias usa Varelisa Centromere Antibodies ANALYTE: Protein, Total (4921) Beckman System 6300 Series Amino Acid (semi-quant.) (16086) TEST SYSTEM, ASSAY OR Analyzer (07553) ANALYTE: Anti-DNA Antibodies (0435) EXAMINATION: ANALYTE: Vitamin B12 (6707) TEST SYSTEM, ASSAY OR STC Diagnostics Total Protein Micro-Plate TEST SYSTEM, ASSAY OR EXAMINATION: Assay (58347) EXAMINATION: Cambridge Life Sciences AUTOZYME ANALYTE: Proteolytic enzymes (4965) Bio-Rad Quantaphase II (07532) (10206) Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25969

Cambridge Life Sciences AUTOZYME elias usa Synelisa ENA Screen (semi- Cambridge Life Sciences AUTOZYME Screen (10263) quantitative) (16065) (10206) Cambridge Life Sciences SELISA Anti- elias usa Synelisa Jo-1 Antibodies EIA Kit Cambridge Life Sciences AUTOZYME nDNA Ab Kit (10264) (16038) Screen (10263) Clark Laboratories Encore dsDNA EIA Test elias usa Varelisa Jo-1 Antibodies Clark Laboratories ENA Combined Test Kit (10238) (qualitative) (16081) (10255) Helix Diagnostics EIA Anti-dsDNA Test elias usa Varelisa Jo-1 Antibodies (semi- Clark Laboratories Encore Sm/RNP Antigen (25171) quantitative) (16082) EIA Test (10240) Immco Diagnostics Anti-dsDNA Antibody ANALYTE: Anti-Mitochondrial Antibodies Helix Diagnostics EIA Extractable Nuclear Test (28276) (AMTA) (0439) Antigen Test (25157) Immco Diagnostics Anti-native DNA Hemagen ENA Screen 6 Kit (25160) Antibody Test (28312) TEST SYSTEM, ASSAY OR EXAMINATION: INOVA Diagnostics QUANTA Lite RNP Sigma Anti-dsDNA Kit (58346) ELISA (28236) The Binding Site BINDAZYME a-dsDNA INOVA Diagnostics QUANTA Lite Mitochondria M2 ELISA (28270) Immco Diagnostics Anti-ENA Antibody EIA Kit (61112) Test (28317) The Binding Site Crithidia luciliae dsDNA Immco Diagnostics Autoantibody Test Immco Diagnostics Anti-RNP and Anti-Sm Kit (61109) System (28311) Antibody Test (28314) Zeus Autoantibody Profile-6 ELISA Test elias usa Synelisa M2 Antibodies EIA Kit Immunco Concepts RELISA ENA Antibody System (79042) (16036) Screening Test (28330) elias usa Synelisa dsDNA Antibodies ANALYTE: Anti-Myeloperoxidase (MPO) Molecular Immunodiagnostics RNP EIA (16019) Antibodies (0505) Test Kit (40184) elias usa elias dsDNA Abs EIA Kit (16031) TEST SYSTEM, ASSAY OR The Binding Site ENA Screening CIE Kit EXAMINATION: ANALYTE: Anti-ENA Antibodies (0507) (61114) Shield Diagnostics DIASTAT Anti-MPO TEST SYSTEM, ASSAY OR Zeus Autoantibody Profile-6 ELISA Test EXAMINATION: (qualitative) (58331) System (79042) INOVA Diagnostics QUANTA Lite ENA 5 Shield Diagnostics DIASTAT Anti-MPO Zeus ENA Profile-6 ELISA Test System ELISA (28365) (semi-quantitative) (58332) (79045) Shield Diagnostics DIASTAT ENA Single ANALYTE: Anti-Neutrophil Cytoplasm elias usa Synelisa ENA Screen (qualitative) Well Screen Kit (58345) Antibodies (0440) (16064) Zeus ENA Screen ELISA Test System TEST SYSTEM, ASSAY OR elias usa Synelisa ENA Screen (79044) EXAMINATION: (semiquantitative) (16065) ANALYTE: Anti-Endomysial Antibodies Shield Diagnostics DIASTAT Anti-PR3 elias usa Synelisa Sm Abs/RNP-Sm Abs (EMA) (0497) (cANCA) (58329) (16037) TEST SYSTEM, ASSAY OR ANALYTE: Anti-Nuclear Antibodies (ANA) ANALYTE: Anti-RNP-Sm Antibodies (0502) EXAMINATION: (0441) Immco Diagnostics Anti-Endomysial TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR Antibody (EMA) Test (28281) EXAMINATION: EXAMINATION: Helix Diagnostics Anti-SM/RNP EIA ANALYTE: Anti-Histone Antibodies (0437) INOVA Diagnostics QUANTA Lite ENA 4 Antibody Test (25165) TEST SYSTEM, ASSAY OR ELISA (28235) elias usa Synelisa ANA Profile (16058) EXAMINATION: Immco Diagnostics Autoantibody Test elias usa Varelisa RNP-Sm Antibodies BioWhittaker RheumELISA II (07488) System (28311) (qualitative) (16079) Cambridge Life Sciences AUTOZYME Immuno Concepts HEp-2000 Fluorescent elias usa Varelisa RNP-Sm Antibodies Screen (10263) ANA Test System (28366) (semi-quantitative)(16080) INOVA Diagnostics QUANTA Lite Histone Light Diag. ANA Test Kit with Mouse Liver ANALYTE: Anti-Reticulin Antibodies (0444) ELISA (28332) Substrate (37097) Immco Diagnostics ImmuLisa Anti-Histone TEST SYSTEM, ASSAY OR Light Diag. ANA Test Kit with Rat Liver Ab ELISA (28354) EXAMINATION: Substrate (37098) elias usa Synelisa Histone Antibodies EIA Immco Diagnostics Anti-Reticulin Shield Diagnostics Anti-Nuclear Antibody Kit (16041) Antibody (ARA) Test (28331) (ANA) Kit (58313) ANALYTE: Anti-SS-A/Ro (0446) ANALYTE: Anti-Jo-1 (0438) Tissue Culture Biotec ANA Test System TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR (61108) EXAMINATION: EXAMINATION: Zeus ANA Screen ELISA (79043) Advanced Biological Products ELISA– Advanced Biological Products ELISA– elias usa ANA Total EIA Kit (16063) DOXA Combi-4 (04505) DOXA Combi-6 (04504) elias usa Synelisa ANA Total (16054) Advanced Biological Products ELISA– Advanced Biological Products ELISA– elias usa Synelisa ANA–8 Screen (16074) DOXA Combi-6 (04504) DOXA Jo-1 (04503) elias usa Varelisa ANA–8 Screen (16071) BioWhittaker RheumELISA II (07488) Advanced Biological Products ELISA– Cambridge Life Sciences AUTOZYME ANALYTE: Anti-Parietal Cell Antibodies DOXA SSb Kit (04510) (10206) (0442) Apotex ANA Profile I (04507) Hemagen ENA Screen 6 Kit (25160) TEST SYSTEM, ASSAY OR Cambridge Life Sciences AUTOZYME Hemagen Jo-1 ENA Kit (qualitative) (25190) EXAMINATION: (10206) Hemagen Jo-1 ENA Kit (semi-quantitative) Immco Diagnostics Autoantibody Test Cambridge Life Sciences AUTOZYME (25195) System (28311) Screen (10263) INOVA Diagnostics QUANTA Lite Jo-1 elias usa Synelisa Parietal Cell Antibodies Clark Laboratories ENA Combined Test Kit ELISA (28273) EIA Kit (16040) (10255) Immuno Concepts RELISA ENA Antibody ANALYTE: Anti-RNP (Ribonucleoprotein) Clark Laboratories Encore SS–A Antigen Screening Test (28330) (0443) EIA Test (10241) Molecular Immunodiagnostics Jo-1 EIA TEST SYSTEM, ASSAY OR Helix Diagnostics Anti–SS–A/Ro EIA Test Kit (40182) EXAMINATION: Antibody Test (25148) The Binding Site ENA Screening CIE Kit Advanced Biological Products ELISA– Helix Diagnostics EIA Extractable Nuclear (61114) DOXA Combi-4 (04505) Antigen Test (25157) Zeus ENA Profile-6 ELISA Test System Advanced Biological Products ELISA– Hemagen ENA Screen 6 Kit (25160) (79045) DOXA Combi-6 (04504) Hemagen SS–A (Ro) ENA Kit (qualitative) elias usa Synelisa ANA Profile (16058) Advanced Biological Products ELISA– (25187) elias usa Synelisa ENA Screen (qualitative) DOXA Sm/RNP Kit (04506) Hemagen SS–A (Ro) ENA Kit (semi- (16064) Apotex ANA Profile I (04507) quantitative) (25192) 25970 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

INOVA Diagnostics QUANTA Lite SS–A elias usa Varelisa SS–B/Ro Antibodies Hemagen Sm ENA Kit (qualitative) (25196) ELISA (28238) (semi-quantitative) (16090) Hemagen Sm ENA Kit (semi-quantitative) Immco Diagnostics Anti-ENA Antibody ANALYTE: Anti-Sal-70 (0448) (25197) Test (28317) TEST SYSTEM, ASSAY OR INOVA Diagnostics QUANTA Lite SM Immco Diagnostics Anti–SS–A(Ro) and EXAMINATION: ELISA (28237) Anti–SS–B(La) Test (28315) Advanced Biological Products ELISA– Immco Diagnostics Anti-ENA Antibody Immuno Concepts RELISA ENA Antibody DOXA Combi–6 (04504) Test (28317) Screening Test (28330) Advanced Biological Products ELISA– Immco Diagnostics Anti–RNP and Anti– Molecular Immunodiagnostics Ro EIA Test DOXA Scl70 Kit (04511) Sm Antibody Test (28314) Kit (40183) BioWhittaker RheumELISA II (07488) Immuno Concepts RELISA ENA Antibody The Binding Site ENA Screening CIE Kit Cambridge Life Sciences AUTOZYME Screening Test (28330) (61114) (10206) Molecular Immunodiagnostics SM EIA Zeus Autoantibody Profile-6 ELISA Test Clark Laboratories ENA Combined Test Kit Test Kit (40185) System (79042) (10255) The Binding Site ENA Screening CIE Kit Zeus ANA Profile-6 ELISA Test System Hemagen ENA Screen 6 Kit (25160) (61114) (79045) Hemagen Scl-70 ENA Kit (qualitative) Zeus Autoantibody Profile-6 ELISA Test elias usa Synelisa ANA Profile (16058) (25188) System (79042) elias usa Synelisa ENA Screen (qualitative) Hemagen Scl-70 ENA Kit (semi- Zeus ANA Profile-6 ELISA Test System (16064) quantitative) (25193) (79045) elias usa Synelisa ENA Screen INOVA Diagnostics QUANTA Lite Scl-70 elias usa Synelisa ANA Profile (16058) (semiquantitative) (16065) ELISA (28274) elias usa Synelisa ENA Screen (qualitative) elias usa Synelisa Ro-Abs/La-Abs (16042) Immco Diagnostics Anti-Scl-70 Antibody (16064) elias usa Varelisa SS–A/Ro Antibodies Test (28316) elias usa Synelisa ENA Screen (qualitative) (16091) Immuno Concepts RELISA ENA Antibody (semiquantitative) (16065) elias usa Varelisa SS–A/Ro Antibodies Screening Test (28330) elias usa Synelisa Sm Abs/RNP-Sm Abs (semi-quantitative) (16092) Molecular Immunodiagnostics Scl-70 EIA (16037) Test Kit (40181) ANALYTE: Anti–SS–B/La (0447) elias usa Varelisa Sm Antibodies The Binding Site ENA Screening CIE Kit (qualitative) (16087) TEST SYSTEM, ASSAY OR (61114) EXAMINATION: elias usa Varelisa Sm Antibodies (semi- Zeus Autoantibody Profile-6 ELISA Test quantitative) (16088) Advanced Biological Products ELISA– System (79042) ANALYTE: Anti-Smooth Muscle Antibodies DOXA Combi-4 (04505) Zeus ANA Profile-6 ELISA Test System (ASMA) (0451) Advanced Biological Products ELISA– (79045) TEST SYSTEM, ASSAY OR DOXA Combi–6 (04504) elias usa Synelisa ANA Profile (16058) EXAMINATION: Advanced Biological Products ELISA– elias usa Synelisa ENA Screen (qualitative) DOXA SSb Kit (04510) (16064) Immco Diagnostics Autoantibody Test Apotex ANA Profile I (04507) elias usa Synelisa ENA Screen System (28311) Cambridge Life Sciences AUTOZYME (semiquantitative) (16065) ANALYTE: Anti-Thyroglobulin Antibodies (10206) elias usa Synelisa Scl-70 Antibodies EIA (0453) Clark Laboratories ENA Combined Test Kit Kit (16039) TEST SYSTEM, ASSAY OR (10255) elias usa Varelisa Scl-70 Antibodies EXAMINATION: Clark Laboratories Encore SS–B Antigen (qualitative) (16083) Biomerica Anti-Thyroglobulin ELISA EIA Test (10243) elias usa Varelisa Scl-70 Antibodies (semi- (07531) Helix Diagnostics Anti–SS–B/La EIA quantitative) (16084) Clark Laboratories Encore Thyroglobulin Antibody Test (25147) ANALYTE: Anti-Skin Antibodies (0449) EIA Test (10239) Helix Diagnostics EIA Extractable Nuclear TEST SYSTEM, ASSAY OR Cogent Diagnostics AUTOSTAT Antigen Test (25157) EXAMINATION: Autoantibody Test Kit (10207) Hemagen ENA Screen 6 Kit (25160) Immco Diagnostics Anti-Skin Antibody Cogent Diagnostics AUTOSTAT II Hemagen SS–B (La) ENA Kit (qualitative) Test (28313) Autoantibody Test Kit (10267) INOVA Diagnostics QUANTA Lite Thyroid (25186) ANALYTE: Anti-Sm (Smith) (0450) T ELISA (28271) Hemagen SS–B (La) ENA Kit (semi- TEST SYSTEM, ASSAY OR Immunoprobe Thyroglobulin EIA Test Kit quantitative) (25191) EXAMINATION: (28348) INOVA Diagnostics QUANTA Lite SS–B Advanced Biological Products ELISA– Joldon Diagnostics Thyroglobulin Auto ELISA (28239) DOXA Combi-4 (04505) Antibody EIA Kit (31010) Immco Diagnostics Anti-ENA Antibody Advanced Biological Products ELISA– Test (28317) DOXA Combi–6 (04504) Nichols Institute Chemiluminescence Anti- Immco Diagnostics Anti–SS–A(Ro) and Advanced Biological Products ELISA– TG Assay (43075) Anti–SS–B(La) Test (28315) DOXA Sm Kit (04509) elias usa Synelisa TG Abs/TPO Abs EIA Kit Immuno Concepts RELISA ENA Antibody Advanced Biological Products ELISA– (16032) Screening Test (28330) DOXA Sm/RNP Kit (04506) elias usa elias TGAb EIA Kit (16034) Molecular Immunodiagnostics Ro EIA Test Apotex ANA Profile I (04507) ANALYTE: Anti-Thyroid Microsomal Kit (40186) Cambridge Life Sciences AUTOZYME Antibodies (AMA) (0455) The Binding Site ENA Screening CIE Kit (10206) TEST SYSTEM, ASSAY OR (61114) Cambridge Life Sciences AUTOZYME EXAMINATION: Zeus Autoantibody Profile-6 ELISA Test Screen (10263) Cogent Diagnostics AUTOSTAT System (79042) Clark Laboratories ENA Combined Test Kit Autoantibody Test Kit (10207) Zeus ANA Profile-6 ELISA Test System (10255) INOVA Diagnostics QUANTA Lite Thyroid (79045) Clark Laboratories Encore Sm Antigen EIA M ELISA (28272) elias usa Synelisa ANA Profile (16058) Test (10244) Immunoprobe Microsomal EIA Test Kit elias usa Synelisa ENA Screen (qualitative) Clark Laboratories Encore Sm/RNP Antigen (28349) (16064) EIA Test (10240) Joldon Diagnostics TMA Auto-Antibody elias usa Synelisa ENA Screen Helix Diagnostics EIA Anti–Sm Ab Test EIA Kit (31009) (semiquantitative) (16065) (25162) Polymedco LUMItest anti-TPO (computer elias usa Synelisa Ro-Abs/La-Abs (16042) Helix Diagnostics EIA Extractable Nuclear calculations) (49109) elias usa Varelisa SS–B/Ro Antibodies Antigen Test (25157) Polymedco LUMItest anti-TPO (manual (qualitative) (16089) Hemagen ENA Screen 6 Kit (25160) calculations) (49110) Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25971

elias usa elias TMAb EIA Kit (16035) Becton Dickinson FACSCount System TEST SYSTEM, ASSAY OR ANALYTE: Anti-Trypanosoma cruzi (07601) EXAMINATION: Antibodies (0503) ANALYTE: CD3/HLA–DR positive DAKO Helicobacter pylori IgG Test Kit TEST SYSTEM, ASSAY OR Lymphocytes (1115) (13342) EXAMINATION: TEST SYSTEM, ASSAY OR Meridian Premier H. pylori EIA Abbott COMMANDER System (04334) EXAMINATION: (spectrophotometric) (40199) Abbott Chagas Antibody EIA (IgG) (04535) Becton Dickinson FACScan Flow Meridian Premier H. pylori EIA (visual) Gull Laboratories Chagas IgG ELISA Cytometer (07497) (40198) (22173) ANALYTE: CD4 positive Lymphocytes (1116) United Biotech UBI MAGIWEL H. pylori ANALYTE: Anti-U1-snRNP Antibodies TEST SYSTEM, ASSAY OR IgG Test (64025) (0501) EXAMINATION: ANALYTE: Herpes simplex I and/or II TEST SYSTEM, ASSAY OR Coulter CD4 Cytospheres Kit (10248) Antibodies (2530) EXAMINATION: ANALYTE: CD4/CD3 positive Lymphocytes TEST SYSTEM, ASSAY OR elias usa Synelisa ANA Profile (16058) (1117) EXAMINATION: elias usa Synelisa ENA Screen (qualitative) TEST SYSTEM, ASSAY OR Baxter Bartels Herpes simplex-1 Virus IgG (16064) EXAMINATION: PRIMA System EIA (07506) elias usa Synelisa ENA Screen Becton Dickinson FACSCount System Baxter Bartels Herpes simplex-1 Virus IgM (semiquantitative) (16065) (07601) PRIMA System EIA (07505) elias usa Synelisa U1-snRNP Antibodies ANALYTE: CD8 positive Lymphocytes (1118) Baxter Bartels Herpes simplex-2 Virus IgG EIA Kit (16033) TEST SYSTEM, ASSAY OR PRIMA System EIA (07508) ANALYTE: B1 positive Lymphocytes (0735) EXAMINATION: Baxter Bartels Herpes simplex-2 Virus IgM TEST SYSTEM, ASSAY OR Coulter CD8 Cyto-Spheres Kit (10270) PRIMA System EIA (07507) EXAMINATION: ANALYTE: CD8/CD3 positive Lymphocytes ANALYTE: Immunoglobulins—monoclonal/ Coulter Clone Immunophenotyping by (1119) polyclonal (2802) Fluorescence Microscopy (10253) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR Coulter Epics Flow Cytometer (10246) EXAMINATION: EXAMINATION: ANALYTE: B4 positive Lymphocytes (0736) Becton Dickinson FACSCount System Helena Laboratories REP ImmunoFix TEST SYSTEM, ASSAY OR (07601) (25133) EXAMINATION: ANALYTE: Coxiella burnetti (Q Fever) Helena Laboratories Titan Gel Immunofix- Coulter Clone Immunophenotyping by Antibodies (1067) 9 Procedure (25149) Fluorescence Microscopy (10253) TEST SYSTEM, ASSAY OR The Binding Site IFE and Zone Coulter Epics Flow Cytometer (10246) EXAMINATION: Electrophoresis Kit (61117) ANALYTE: Beta-2 microglobulin (0703) Hillcrest Biologicals Q Fever (IgG) IFA Test The Binding Site Immunofixation (IFE) Kit TEST SYSTEM, ASSAY OR (25131) (61115) EXAMINATION: Hillcrest Biologicals Q Fever (IgM) IFA ANALYTE: Immunoglobulins IgA (2803) Coulter Beta-2 Microglobulin EIA (10205) Test (25130) TEST SYSTEM, ASSAY OR T Cell Diagnostics CELLFREE Beta-2 M ANALYTE: Cytomegalovirus Antibodies EXAMINATION: Test Kit (61120) (1039) Crestat Diagnostics N-Assay TIA IgA Wallac Oy DELFIA B–2 Micro Kit (70158) TEST SYSTEM, ASSAY OR (manual procedure) (10258) ANALYTE: Blastomyces Antibodies (0724) EXAMINATION: ANALYTE: Immunoglobulins IgA subclasses TEST SYSTEM, ASSAY OR Abbott CMV–M EIA (04524) (2827) EXAMINATION: Baxter Bartels Cytomegalovirus IgG PRIMA TEST SYSTEM, ASSAY OR Meridian Diagnostics Premier Blastomyces System EIA (07502) EXAMINATION: Baxter Bartels Cytomegalovirus IgM EIA (40148) The Binding Site Human IgA Subclasses PRIMA System EIA (07501) ANALYTE: C-Reactive Protein (CRP) (1001) NL RID Kit (61111) TEST SYSTEM, ASSAY OR DAKO IDEIA CMV–M (13339) DAKO IDEIA CMV–M (13338) ANALYTE: Immunoglobulins IgE (2805) EXAMINATION: TEST SYSTEM, ASSAY OR Hemagen C-Relative Protein Kit (25172) Zeus CMV ELISA (simultaneous IgM & IgG) Test System (79040) EXAMINATION: ANALYTE: CD3 (IgG1) positive Lymphocytes Abbott IgE EIA (04472) ANALYTE: Epstein-Barr virus Antibodies (1111) Diagnostics Products Corp. AlaTOP (1603) TEST SYSTEM, ASSAY OR Microplate Allergy Screen (13293) TEST SYSTEM, ASSAY OR EXAMINATION: Hycor HY–TEC Total IgE EIA (25161) Coulter Clone Immunophenotyping by EXAMINATION: Baxter Bartels Epstein-Barr Virus IgG MAST CLA Allergy System (densitometer) Fluorescence Microscopy (10253) (40176) Coulter Epics Flow Cytometer (10246) PRIMA System EIA (07504) Baxter Bartels Epstein-Barr Virus IgM MAST CLA–1 Chemiluminescent Allergy ANALYTE: CD3 (IgG1)/B4 positive PRIMA System EIA (07503) System (40177) Lymphocytes (1112) Fuller Laboratories EBV–EA IgG AB IFA Roche Cobas Core IgE Total EIA (manual TEST SYSTEM, ASSAY OR Kit (19017) procedure) (55120) EXAMINATION: Fuller Laboratories EBV–EBNA IFA Kit The Binding Site IgE EIA Test Kit (61105) Coulter Epics Flow Cytometer (10246) (19018) Wallac Oy DELFIA Total IgE Kit (70163) ANALYTE: CD3 (IgG1)/T4 positive Fuller Laboratories EBV–VCA IgG Ab IFA ANALYTE: Immunoglobulins IgG (2806) Lymphocytes (1113) Kit (19016) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR Incstar Clin–ELISA EBV EA(D) IgG (28266) EXAMINATION: EXAMINATION: MRL Diagnostics Epstein-Barr Virus rVCA Crestat Diagnostics N-Assay TIA IgG Coulter Epics Flow Cytometer (10246) IgM (40194) (manual procedure) (10256) ANALYTE: CD3 (IgG1)/T8 positive Ortho Epstein-Barr Virus EA(D∂R)-IgG ANALYTE: Immunoglobulins IgG in tissue Lymphocytes (1114) Antibody ELISA Test (46146) samples (2830) TEST SYSTEM, ASSAY OR Ortho Epstein-Barr Virus EBNA-IgG TEST SYSTEM, ASSAY OR EXAMINATION: Antibody ELISA Test (46142) EXAMINATION: Coulter Epics Flow Cytometer (10246) Virion EBV Combi Test (67085) Ventana AEC Detection Kit (for tissue ANALYTE: CD3 positive Lymphocytes (1110) Zeus EBV–VCA IgG Elisa (79039) sample) (67081) TEST SYSTEM, ASSAY OR ANALYTE: Helicobacter pylori Antibodies Ventana DAB Detection Kit (for tissue EXAMINATION: (2513) sample) (67083) 25972 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

Ventana Red, Alk.Phos. Fast Red Detect. TheraTest Laboratories EL–RF–IgM Kit TEST SYSTEM, ASSAY OR Kit (tissue sample) (67082) (61134) EXAMINATION: ANALYTE: Immunoglobulins IgG subclasses ANALYTE: Rubella Antibodies (5510) Baxter Bartels Toxo IgG PRIMA System (2807) TEST SYSTEM, ASSAY OR EIA (07515) TEST SYSTEM, ASSAY OR EXAMINATION: Baxter Bartels Toxo IgG PRIMA System EXAMINATION: Baxter Bartels Rubella Virus IgG PRIMA EIA (07514) Research Diagnostics Human IgG Subclass System EIA (07513) DAKO IDEIA Toxo–G (13340) RID Combi Kit (55151) Baxter Bartels Rubella Virus IgM PRIMA DAKO IDEIA Toxo–M (13341) Research Diagnostics IgG Subclass ELISA System EIA (07512) Zeus Toxo IgM Test System (79041) Combi Kit (55138) DAKO IDEIA Rubella-G (13343) SPECIALITY/SUBSPECIALITY: Hematology DAKO IDEIA Rubella-M (13344) ANALYTE: Immunoglobulins IgM (2808) ANALYTE: Activated Partial Thromboplastin TEST SYSTEM, ASSAY OR ANALYTE: Rubeola Antibodies (measles) Time (APTT) (0409) EXAMINATION: (5511) TEST SYSTEM, ASSAY OR Crestat Diagnostics N-Assay TIA IgM TEST SYSTEM, ASSAY OR EXAMINATION: (manual procedure) (10259) EXAMINATION: Helena Laboratories APTT–ES (manual) ANALYTE: Immunoglobulins IgM in tissue Baxter Bartels Rubeola Virus IgG PRIMA (25158) samples (2831) System EIA (07511) MeDiTech APTT–ES (manual) (40192) TEST SYSTEM, ASSAY OR Baxter Bartels Rubeola Virus IgM PRIMA Vitek HEMOLAB Silimat (manual) (67089) System EIA (07510) EXAMINATION: ANALYTE: Activated Plasma Clotting Time Ventana AEC Detection Kit (for tissue ANALYTE: T1 positive Lymphocytes (6145) (APCT) (0499) sample) (67081) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR Ventana DAB Detection Kit (for tissue EXAMINATION: EXAMINATION: sample) (67083) Coulter Clone Immunophenotyping by All Manual Tilt-Tube Coagulation Ventana Red, Alk.Phos. Fast Red Detect. Fluorescence Microscopy (10253) Procedures (04424) Coulter Epics Flow Cytometer (10246) Kit (tissue sample) (67082) ANALYTE: Alpha-2-Antiplasmin (0463) ANALYTE: Interleukin-2 Receptor (IL–2R) ANALYTE: T11 positive Lymphocytes (6146) TEST SYSTEM, ASSAY OR (2821) TEST SYSTEM, ASSAY OR EXAMINATION: TEST SYSTEM, ASSAY OR EXAMINATION: Medical Laboratory MLA Electra 1600C EXAMINATION: Coulter Clone Immunophenotyping by (40167) Fluorescence Microscopy (10253) T Cell Diagnostics CELLFREE Interleukin- ANALYTE: Antithrombin III (ATIII) (0456) 2 Receptor Kit (61119) ANALYTE: T11/B1 positive Lymphocytes TEST SYSTEM, ASSAY OR ANALYTE: Lyme Disease Antibodies (6147) EXAMINATION: (Borrelia burgdorferi Abs) (3714) TEST SYSTEM, ASSAY OR American Bioproducts STA Analyzer TEST SYSTEM, ASSAY OR EXAMINATION: (04594) EXAMINATION: Coulter Epics Flow Cytometer (10246) Baxter Antithrombin III Chromogenic Baxter Bartels B. burgdorferi (Lyme) IgM ANALYTE: T11/B4 positive Lymphocytes Assay (07535) PRIMA System EIA (07509) (6148) Dade Thrombin-Antithrombin (TAT) ANALYTE: MY4 positive Lymphocytes TEST SYSTEM, ASSAY OR Complex ELISA (13292) (4033) EXAMINATION: Kabi Pharmacia COATEST Antithrombin TEST SYSTEM, ASSAY OR Coulter Epics Flow Cytometer (10246) (manual) (34061) EXAMINATION: ANALYTE: T3 positive Lymphocytes (6149) Medical Laboratory MLA Electra 1600C Coulter Clone Immunophenotyping by TEST SYSTEM, ASSAY OR (40167) Fluorescence Microscopy (10253) EXAMINATION: Organon Teknika Multi Channel Discrete Coulter Epics Flow Cytometer (10246) Coulter Clone Immunophenotyping by Analyzer (MDA–180) (46144) ANALYTE: Mo2 positive Lymphocytes Fluorescence Microscopy (10253) Sigma ACCUCOLOR Antithrombin III (4034) Coulter Epics Flow Cytometer (10246) (58320) TEST SYSTEM, ASSAY OR ANALYTE: T4 positive Lymphocytes (6150) Vitek HEMOLAB (67075) EXAMINATION: TEST SYSTEM, ASSAY OR ANALYTE: Coagulation Factors (1044) Coulter Clone Immunophenotyping by EXAMINATION: TEST SYSTEM, ASSAY OR Fluorescence Microscopy (10253) Coulter Clone Immunophenotyping by EXAMINATION: Coulter Epics Flow Cytometer (10246) Fluorescence Microscopy (10253) Diagnostica Stago Deficient II Factor Assay (manual) (13297) ANALYTE: Mumps Antibodies (4007) Coulter Epics Flow Cytometer (10246) Diagnostica Stago Deficient V Factor Assay TEST SYSTEM, ASSAY OR ANALYTE: T4/T8 positive Lymphocytes (manual) (13296) EXAMINATION: (6151) Diagnostica Stago Deficient VII Factor Bion Mumps-G Antibody Test System TEST SYSTEM, ASSAY OR Assay (manual) (13305) (07480) EXAMINATION: Coulter Epics Flow Cytometer (10246) Diagnostica Stago Deficient X Factor Assay ANALYTE: Mycoplasma pneumoniae (manual) (13306) ANALYTE: T8 positive Lymphocytes (6152) Antibodies (4016) Diagnostica Stago Deficient XI Factor TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR Assay (manual) (13307) EXAMINATION: EXAMINATION: Diagnostica Stago Deficient XII Factor Coulter Clone Immunophenotyping by Fuller Laboratories Mycoplasma Assay (manual) (13304) Fluorescence Microscopy (10253) pneumoniae IgG Antibody Kit (19021) Helena Laboratories Cascade M (25156) Coulter Epics Flow Cytometer (10246) Shared Systems M. pneumoniae Antibody Instrumentation Laboratory MCL 2 EIA Test System (58287) ANALYTE: Thyroid Peroxidase Coagulation Analyzer (28297) ANALYTE: Rheumatoid Factor (RF) (5508) Autoantibodies (TPO) (6135) International Technidyne Factor VI (28093) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR International Technidyne Factor VI EXAMINATION: EXAMINATION: Premier (28296) Clark Laboratories Encore Rheumatoid Nichols Institute Chemiluminescence Anti- International Technidyne Hemochron 400 Factor (RF) EIA Test (10242) TPO Assay (43076) (28094) Immco Diagnostics ImmuLisa Rheumatoid elias usa Synelisa TG Abs/TPO Abs EIA Kit International Technidyne Hemochron 401 Factor ELISA (28352) (16032) (28095) Sigma Diagnostics Rheumatoid Factor IgM ANALYTE: Toxoplasma gondii Antibodies International Technidyne Hemochron 800 Kit (58333) (6113) (28096) Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25973

International Technidyne Hemochron 8000 SmithKline ESKALAB–CHS H5–M (58302) Texas International Laboratories Plt–4 (28298) SmithKline ESKALAB–CHS H7 (58304) (61126) International Technidyne Hemochron 801 Texas International Laboratories H10 ANALYTE: Protamine Response Test (PRT) (28097) (61127) (4945) MeDiTech Chromogenic Factor VIII:C Texas International Laboratories H3–Hgb TEST SYSTEM, ASSAY OR Assay Kit (40180) (61122) EXAMINATION: Medical Laboratory MLA Electra 1600C Texas International Laboratories H5 International Technidyne Hemochron 8000 (40167) (61124) (28298) Organon Teknika Multi Channel Discrete Texas International Laboratories H5–M ANALYTE: Protein C (4929) Analyzer (MDA–180) (46144) (61123) TEST SYSTEM, ASSAY OR TOA Medical Electronics CA–1000 (61132) Texas International Laboratories H7 EXAMINATION: TOA Medical Electronics CA–5000 (61135) (61125) Behring Fibrintimer A (07516) Vitek HEMOLAB (67075) ANALYTE: Heparin (2518) Boehringer Mannheim Hitachi 704 (07161) ANALYTE: Fibrin Monomers (1927) TEST SYSTEM, ASSAY OR Boehringer Mannheim Hitachi 705 (07162) TEST SYSTEM, ASSAY OR EXAMINATION: Boehringer Mannheim Hitachi 717 (07163) EXAMINATION: Behring Berichrome Heparin (07481) Chromogenix COAMATE Protein C Protamine Sulfate (with serial dilutions) Biopool Spectrolyse Heparin (07526) (manual procedure) (10252) (49106) Vitek HEMOLAB (67075) Medical Laboratory MLA Electra 1600C ANALYTE: Fibrinogen (1905) Vitek HEMOLAB Heparichrom (67095) (40167) TEST SYSTEM, ASSAY OR ANALYTE: Heparin, Low Molecular Weight Organon Teknika Multi Channel Discrete EXAMINATION: (LMWH) (2558) Analyzer (MDA–180) (46144) Roche Cobas Bio (55100) All Manual Tilt-Tube Coagulation TEST SYSTEM, ASSAY OR Roche Cobas FARA (55040) Procedures (04424) EXAMINATION: Roche Cobas Mira (55044) Behring Multifibren U (manual) (07545) Instrumentation Laboratory IL Test The Binding Site Human Protein C RID Behring Multifibrin (manual) (07517) Heparin (Xa) (28341) Diagnostic Specialties EnZIP Test Kit (61180) Immunoturbidometric (manual) (13319) ANALYTE: Heparin/Protamine Titration Vitek HEMOLAB (67075) Helena Laboratories Fibrinogen Assay Kit (HPT) (2538) Vitek HEMOLAB Protein C chrom (manual (manual) (25152) TEST SYSTEM, ASSAY OR procedure) (67086) EXAMINATION: The Binding Site Human Fibrinogen RID ANALYTE: Protein S (4930) International Technidyne Factor VI (28093) (61101) TEST SYSTEM, ASSAY OR International Technidyne Hemochron 400 EXAMINATION: ANALYTE: Hematocrit (2514) (28094) TEST SYSTEM, ASSAY OR Instrumentation Laboratory IL ACL 100 International Technidyne Hemochron 401 (28073) EXAMINATION: (28095) DMA H10 (13283) Instrumentation Laboratory IL ACL 1000 International Technidyne Hemochron 800 (28074) DMA H3–HCT (13277) (28096) DMA H5 (13280) Instrumentation Laboratory IL ACL 200 International Technidyne Hemochron 801 (28075) DMA H5–M (13279) (28097) DMA H7 (13281) Instrumentation Laboratory IL ACL 2000 Mallinckrodt H5–M (40171) ANALYTE: Lupus Anticoagulants (3728) (28076) Mallinckrodt S–610 (40169) TEST SYSTEM, ASSAY OR Instrumentation Laboratory IL ACL 300 Mallinckrodt S–650 (40172) EXAMINATION: (28077) Mallinckrodt S–670 (40173) American Diagnostica DVVtest Instrumentation Laboratory IL ACL 300 SmithKline ESKALAB–CHS H10 (58305) &DVVconfirm (manual) (04543) Plus (28197) SmithKline ESKALAB–CHS H3–HCT Biopool Bioclot LA (manual procedure) Instrumentation Laboratory IL ACL 3000 (58300) (07522) (28078) SmithKline ESKALAB–CHS H5 (58303) Diagnostica Stago STACLOT LA (13285) Instrumentation Laboratory IL ACL 3000 SmithKline ESKALAB–CHS H5–M (58302) Diagnostica Stago STACLOT PNP (13273) Plus (28079) SmithKline ESKALAB–CHS H7 (58304) Gradipore Lupo-Test II & Lucor (22163) Instrumentation Laboratory IL ACL 810 Texas International Laboratories H10 ANALYTE: Plasminogen (4907) (28080) (61127) TEST SYSTEM, ASSAY OR ANALYTE: Prothrombin Time (PT) (4922) Texas International Laboratories H3–HCT EXAMINATION: TEST SYSTEM, ASSAY OR (61121) American Bioproducts STA Analyzer EXAMINATION: Texas International Laboratories H5 (04594) Helena Laboratories Thromboplastin (61124) Medical Laboratory MLA Electra 1600C Reagent-MI (manual) (25163) Texas International Laboratories H5–M (40167) ANALYTE: Red Blood Cell Count (61123) The Binding Site Plasminogen RID Test Kit (Erythrocyte Count) (RBC) (5502) Texas International Laboratories H7 (61159) TEST SYSTEM, ASSAY OR (61125) ANALYTE: Plasminogen Activator Inhibitor EXAMINATION: ANALYTE: Hemoglobin (2515) (PAI) (4936) DMA H10 (13283) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR DMA H3–HCT (13277) EXAMINATION: EXAMINATION: DMA H3–Hgb (13278) DMA H10 (13283) Baxter Plasminogen Activator Inhibitor-1 DMA H5 (13280) DMA H3–Hgb (13278) (PAI) (07521) DMA H5–M (13279) DMA H5 (13280) Biopool Spectrolyse/pL PAI (07482) DMA H7 (13281) DMA H5–M (13279) ANALYTE: Platelet Count (4908) Mallinckrodt H5–M (40171) DMA H7 (13281) TEST SYSTEM, ASSAY OR Mallinckrodt S–610 (40169) Mallinckrodt H5–M (40171) EXAMINATION: Mallinckrodt S–630 (40170) Mallinckrodt S–630 (40170) DMA H10 (13283) Mallinckrodt S–650 (40172) Mallinckrodt S–650 (40172) DMA Plt–4 (13282) Mallinckrodt S–670 (40173) Mallinckrodt S–670 (40173) Mallinckrodt Plt–4 (40174) SmithKline ESKALAB–CHS H10 (58305) SmithKline ESKALAB–CHS H10 (58305) SmithKline ESKALAB–CHS H10 (58305) SmithKline ESKALAB–CHS H3–HCT SmithKline ESKALAB–CHS H3–Hgb SmithKline ESKALAB–CHS Plt–4 (58306) (58300) (58301) Texas International Laboratories H10 SmithKline ESKALAB–CHS H3–Hgb SmithKline ESKALAB–CHS H5 (58303) (61127) (58301) 25974 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

SmithKline ESKALAB–CHS H5 (58303) Texas International Laboratories H5–M Seradyn Color Vue—Giardia (dir Ag/ SmithKline ESKALAB–CHS H5–M (58302) (61123) spectrophoto) (58183) SmithKline ESKALAB–CHS H7 (58304) Texas International Laboratories H7 Seradyn Color Vue—Giardia (direct Ag/ Texas International Laboratories H10 (61125) visual) (58296) (61127) ANALYTE: von Willebrand Factor Trend Scientific Giardia lamblia Direct Texas International Laboratories H3–HCT (Ristocetin Cofactor) (6711) Detection System (61019) (61121) TEST SYSTEM, ASSAY OR ANALYTE: Pneumocystis (4926) Texas International Laboratories H3–Hgb EXAMINATION: TEST SYSTEM, ASSAY OR (61122) Chrono-log Ristocetin Cofactor Assay EXAMINATION: Texas International Laboratories H5 (10282) Polysciences Fungi-Fluor Pneumocystis (61124) Texas International Laboratories H5–M SPECIALITY/SUBSPECIALITY: Mycology (49099) (61123) ANALYTE: Yeast (7601) SPECIALITY/SUBSPECIALITY: Toxicology/ Texas International Laboratories H7 TEST SYSTEM, ASSAY OR TDM (61125) EXAMINATION: ANALYTE: Amphetamines (0428) ANALYTE: Reptilase Time (5521) Innovative Diag. Systems RapID Yeast Plus TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR System (inc. cult) (28383) EXAMINATION: EXAMINATION: ANALYTE: Yeast, Cryptocococcus only Microdiagnostics MICRO EIA (40191) Behring Batroxobin (manual procedure) (7604) STC Diagnostics Amphetamines EIA Plate (07534) TEST SYSTEM, ASSAY OR Kit (58299) ANALYTE: Reticulocyte Count (5506) EXAMINATION: USDT Flow Immunoassay System (64026) TEST SYSTEM, ASSAY OR Trinity Laboratories CRYPTO–LEX System ANALYTE: Cannabinoids (THC) (1009) EXAMINATION: (61136) Becton Dickinson FACScan Flow TEST SYSTEM, ASSAY OR SPECIALITY/SUBSPECIALITY: Parasitology Cytometer (07497) EXAMINATION: STC Diagnostics Cannabinoids EIA Plate ANALYTE: Semen (5822) ANALYTE: Cryptosporidium (1109) Kit (58292) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR USDT Flow Immunoassay System (64026) EXAMINATION: EXAMINATION: Serono Penetrak (58352) Alexon ProSpecT Cryptosporidium ANALYTE: Cocaine Metabolites (1023) Microtiter (dir Ag/spectro) (04326) TEST SYSTEM, ASSAY OR ANALYTE: Thrombin Time (6105) Alexon ProSpecT Cryptosporidium TEST SYSTEM, ASSAY OR EXAMINATION: Microtiter (dir Ag/visual) (04325) EXAMINATION: USDT Flow Immunoassay System (64026) LMD Laboratories Cryptosporidium Ag Behring Test Thrombin (manual) (07495) ANALYTE: Digoxin (1304) Detect. Microtiter(vis) (37018) Vitek HEMOLAB Thrombicalci-Test TEST SYSTEM, ASSAY OR Meridian Diagnostics MERIFLUOR (manual) (67090) EXAMINATION: Cryptosporidium (40100) ANALYTE: Thrombin/antithrombin III Diatron FAST Test System (13287) Meridian Diagnostics MERIFLUOR Wallac Oy DELFIA Digoxin Kit (70160) Complex (TAT) (6136) Cryptosporidium/Giardia (40095) TEST SYSTEM, ASSAY OR Seradyn Color Vue—Cryptosporidium (dir. ANALYTE: Morphine (4020) EXAMINATION: Ag/spectrophoto) (58184) TEST SYSTEM, ASSAY OR Behring Enzygnost TAT (07483) Seradyn Color Vue—Cryptosporidium EXAMINATION: ANALYTE: Tissue Plasminogen Activator (t- (direct, Ag/visual) (58297) Immunalysis Urine Morphine Direct RIA Kit (28342) PA) (6130) ANALYTE: Entamoeba histolytica (1631) TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR ANALYTE: Opioates (4601) EXAMINATION: EXAMINATION: TEST SYSTEM, ASSAY OR Biopool TintElize tPA (07525) Alexon ProSpecT Entamoeba histolytica EXAMINATION: ANALYTE: White Blood Cell Count (direct Ag/spectro) (04530) Microdiagnostics Micro EIA Opiate (Leukocyte Count) (WBC) (7002) Alexon ProSpecT Entamoeba histolytica Metabolites (40168) TEST SYSTEM, ASSAY OR (direct Ag/visual) (04529) STC Diagnostics Opiates EIA Plate Kit EXAMINATION: (58298) ANALYTE: Giardia lamblia (2222) DMA H10 (13283) USDT Flow Immunoassay System (64026) TEST SYSTEM, ASSAY OR DMA H3–HCT (13277) EXAMINATION: ANALYTE: Phencyclidine (PCP) (4901) DMA H3–Hgb (13278) Alexon ProSpecT Giardia EZ Microplate TEST SYSTEM, ASSAY OR DMA H5 (13280) Assay (dir Ag/spectr) (04585) EXAMINATION: DMA H5–M (13279) USDT Flow Immunoassay System (64026) DMA H7 (13281) Alexon ProSpecT Giardia EZ Microplate Mallinckrodt H5–M (40171) Assay (dir Ag/visual) (04586) SPECIALITY/SUBSPECIALITY: Virology Alexon ProSpecT Giardia Microplate Assay Mallinckrodt S–610 (40169) ANALYTE: Adenovirus (0410) Mallinckrodt S–630 (40170) (dir Ag/spectro) (04557) Alexon ProSpecT Giardia Microplate Assay TEST SYSTEM, ASSAY OR Mallinckrodt S–650 (40172) EXAMINATION: Mallinckrodt S–670 (40173) (dir Ag/visual) (04558) Alexon ProSpecT Giardia Microtiter (dir Baxter Bartels Viral Respiratory Kit SmithKline ESKALAB–CHS H10 (58305) (including cell cult) (07359) SmithKline ESKALAB–CHS H3–HCT Ag/spectrophoto) (04257) Alexon ProSpecT Giardia Microtiter (dir Light Diag. Respir. Panel 1 Screen & ID Kit (58300) (inc. cell cult) (37068) SmithKline ESKALAB–CHS H3–Hgb antigen/visual) (04099) (58301) Alexon ProSpecT/Giardia (tube) (dir Ag/ ANALYTE: Cytomegalovirus (1038) SmithKline ESKALAB–CHS H5 (58303) visual) (04338) TEST SYSTEM, ASSAY OR SmithKline ESKALAB–CHS H5–M (58302) Antibodies Inc. Giard EIA (direct antigen/ EXAMINATION: SmithKline ESKALAB–CHS H7 (58304) visual) (04224) Diagnostic Products PathoDx Texas International Laboratories H10 LMD Laboratories G. lamblia Ag Detect. Cytomegalovirus (inc. cell cult) (13298) (61127) Microtiter (spectro) (37032) Light Diag. Cytomegalovirus Indirect Texas International Laboratories H3–HCT LMD Laboratories G. lamblia Ag Detect. Immunofluorescence Kit (37089) (61121) Microtiter (visual) (37019) NeoGenex CMV Early Antigen Test Texas International Laboratories H3–Hgb Meridian Diagnostics MERIFLUOR (including cell culture) (43092) (61122) Cryptosporidium/Giardia (40095) ANALYTE: Herpes simplex (2529) Texas International Laboratories H5 Meridian Diagnostics MERIFLUOR Giardia TEST SYSTEM, ASSAY OR (61124) (40099) EXAMINATION: Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices 25975

DAKO IDEIA Herpes simplex (direct Ag) DAKO IMAGEN Parainfluenza virus Group TCPI One Step LH Test (61158) (13332) (inc. cell culture) (13373) ANALYTE: Urine HCG by Visual Color DAKO IMAGEN Herpes simplex (inc. cell DAKO IMAGEN Parainfluenza virus Types Comparison Tests (9642) culture) (13333) 1,2,3 (inc. cell cult) (13374) TEST SYSTEM, ASSAY OR ANALYTE: Human Papillomavirus (HPV) Light Diag. Respir. Panel 1 Screen & ID Kit EXAMINATION: (2540) (inc. cell cult) (37068) ANI BIOCARD HCG (04549) TEST SYSTEM, ASSAY OR Symex ViraSTAT Anti-Parainfluenza ANI BIOTECH OY BIOCARD HCG (04502) EXAMINATION: MAbs (58315) Abbott TestPack HCG-combo (04074) Digene ViraType Plus HPV DNA Assay ANALYTE: Parainfluenza 3 (4961) Advanced Care Products 1 Easy Step (13323) TEST SYSTEM, ASSAY OR ADVANCE Pregnancy Test (04591) ANALYTE: Influenza A (2828) EXAMINATION: Apotex ProPhase Plus (04534) TEST SYSTEM, ASSAY OR Baxter Bartels Viral Respiratory Kit (direct Apotex ProStrip HCG (04533) EXAMINATION: antigen) (07035) Apothecus VCF One Step Pregnancy Test Analytab API IMAGEN Influenza Virus Baxter Bartels Viral Respiratory Kit (04606) A&B (direct antigen) (04215) (including cell cult) (07359) Applied Biotech SureStep Combo hCG Analytab API IMAGEN Influenza Virus DAKO IMAGEN Parainfluenza virus Group (04528) A&B (inc.cell culture) (04512) (inc. cell culture) (13373) Applied Biotech SureStep HCG Pregnancy Baxter Bartels PRIMA Influenza A EIA DAKO IMAGEN Parainfluenza virus Types Test (04441) (direct Ag/spectro) (07490) 1,2,3 (inc. cell cult) (13374) Applied Biotech SureStick HCG Pregnancy Baxter Bartels PRIMA Influenza A EIA (inc. Light Diag. Respir. Panel 1 Screen & ID Kit Test (04522) cell culture) (07492) (inc. cell cult) (37068) Becton Dickinson Precise One-step Baxter Bartels Viral Respiratory Kit (direct Symex ViraSTAT Anti-Parainfluenza Pregnancy Test (07476) antigen) (07035) MAbs (58315) BioTech Atlantic UniStep HCG Pregnancy Baxter Bartels Viral Respiratory Kit ANALYTE: Respiratory syncytial virus (5503) Test Device (07544) (including cell cult) (07359) TEST SYSTEM, ASSAY OR BioTech Atlantic UniStep HCG Pregnancy DAKO IMAGEN Influenza (direct antigen) EXAMINATION: Test Strips (07543) (13336) Baxter Bartels Viral Respiratory Kit (direct Biomed Diagnostics ProClinic One-Step DAKO IMAGEN Influenza (including cell antigen) (07035) DipStick Pregnancy (07478) culture) (13337) Baxter Bartels Viral Respiratory Kit Boehringer Mannheim BMIt EVATEST Gull Laboratories Influenza A Test (including cell cult) (07359) Test Strip (07550) (including cell culture) (22106) DAKO IMAGEN RSV (direct antigen) Boehringer Mannheim EVENT test strip Light Diag. Respir. Panel 1 Screen & ID Kit (13335) hCG (07533) (inc.cell cult) (37068) Diagnostic Products Corp. PathoDx RSV Disease Detection International Pro-Step NeoGenex Influenza A Antigen Test Kit (direct antigen) (13324) PT hCG (13271) (including cell culture) (40393) Diagnostic Products Corp. PathoDx RSV Disease Detection International Pro-Step ANALYTE: Influenza B (2829) Kit (inc. cell cult.) (13325) hCG (13270) TEST SYSTEM, ASSAY OR Light Diag. Respir. Panel 1 Screen & ID Kit Eucardio Laboratories UC QIK 1-Step HCG EXAMINATION: (inc. cell cult) (37068) Test (16072) Analytab API IMAGEN Influenza Virus NeoGenex RSV Antigen Test (including Eucardio Laboratory UC Qik Pregnancy A&B (direct antigen) (04215) cell culture) (43094) Test (16029) Analytab API IMAGEN Influenza Virus Sanofi/Kallestad RSV Microplate EIA King’s Bay Prelude hCG Combo Kit (34062) A&B (inc. cell culture) (04512) (direct Ag/spectro) (58286) Mainline Technology MAINLINE Confirms Baxter Bartels Viral Respiratory Kit (direct ANALYTE: Rotavirus (5509) hCG (40190) antigen) (07035) TEST SYSTEM, ASSAY OR Medix Biotech BESTest hCG Urine (40166) Baxter Bartels Viral Respiratory Kit EXAMINATION: Mizuho USA HCG Midstream (40178) (including cell cult) (07359) DAKO ELISA Rotavirus Kit (direct Ag/ Organon Teknika Predictor Pregnancy Test DAKO Diagnostics IMAGEN Influenza spectrophoto) (13331) (46151) (direct antigen) (13336) DAKO ELISA Rotavirus Kit (direct Ag/ Pacific Biotech Concise Plus HCG-Urine DAKO Diagnostics IMAGEN Influenza visual) (13330) (49123) (including cell culture) (13337) DAKO IDEIA Rotavirus (direct antigen/ Princeton BioMeditech BioStrip hCG Gull Laboratories Influenza B Test spectro) (13295) (49131) (including cell culture) (22107) DAKO IDEIA Rotavirus (direct antigen/ Princeton BioMeditech LifeSign 1 One- Light Diag. Respir. Panel 1 Screen & ID Kit visual) (13294) Step Home Preg. Test (49127) (inc. cell cult) (37068) ANALYTE: Varicella-Zoster viruses (6705) Princeton BioMeditech LifeSign Plus One NeoGenex Influenza B Antigen Test TEST SYSTEM, ASSAY OR Step Home Pregnancy (49095) (including cell culture) (43096) EXAMINATION: Quidel Conceive 1-Step Pregnancy Test ANALYTE: Parainfluenza 1 (4959) Viro Varicella-Zoster Virus ID Reagent (52021) TEST SYSTEM, ASSAY OR (direct antigen) (67093) Quidel QuickVue One-Step hCG Combo EXAMINATION: Viro Varicella-Zoster Virus ID Reagent (inc. Test (52022) Baxter Bartels Viral Respiratory Kit (direct cell culture) (67094) Quidel QuickVue One-Step hCG Test antigen) (07035) COMPLEXITY: WAIVED (52018) Baxter Bartels Viral Respiratory Kit Quidel RapidVue hCG (52025) (including cell cult) (07359) SPECIALITY/SUBSPECIALITY: SA Scientific Pregnancy Check (58328) DAKO IMAGEN Parainfluenza virus Group Endocrinology SA Scientific SAS One-Step Pregnancy (inc. cell culture) (13373) ANALYTE: Ovulation Test (LH) by Visual (58282) DAKO IMAGEN Parainfluenza virus Types Color Comparison (9461) SA Scientific SAS Pregnancy Strip (58284) 1, 2, 3 (inc. cell cult) (13374) TEST SYSTEM, ASSAY OR SA Scientific SAS Serum/Urine hCG Light Diag. Respir. Panel 1 Screen & ID Kit EXAMINATION: (58283) (inc.cell cult) (37068) Applied Biotech Ovugen 1-Step Ovulation Stanbio QuPid Plus hCG Pregnancy Test Symex ViraSTAT Anti-Parainfluenza Prediction Test (04514) (58326) MAbs (58315) BioGenex OvuGen 1-Step Ovulation Stanbio QuPid visual one-step pregnancy ANALYTE: Parainfluenza 2 (4960) Prediction Test (07477) test (58325) TEST SYSTEM, ASSAY OR Disease Detection Internat. Pro-Step LH Stanbio QuStick visual one-step pregnancy EXAMINATION: Ovulation Pred. Tst (13316) test (58324) Baxter Bartels Viral Respiratory Kit Princeton BioMeditech OvuSign One-Step Sun Biomedical Laboratories Visualine II (including cell cult) (07359) Ovulation Prediction (49093) HCG (58341) 25976 Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / Notices

Syntron Bioresearch Be Sure Plus One Step Ames Glucometer ENCORE Blood Glucose SPECIALITY/SUBSPECIALITY: Urinalysis Pregnancy Test (58285) Test Strips (04501) ANALYTE: Urine Dipstick or Tablet Syntron Bioresearch QuikPac II hCG Ames Glucometer ENCORE QA Blood Analytes, nonautomated (9641) Combo Kit (58353) Glucose Meter (04423) TEST SYSTEM, ASSAY OR TCPI PDQ (Pregnancy Detected Quickly) Ames Glucometer ENCORE System (04500) EXAMINATION: Wand (61166) Ames Glucometer QA Blood Glucose Meter Bio-Scan Bio-Gen 2 (07456) TCPI hCG Pregnancy One Step Test Strip (04422) Bio-Scan Bio-Gen 3 (07455) (61100) Boehringer Mannheim Accu-Chek TCPI hCG Pregnancy One Step Wand Bio-Scan Bio-Gen 4 (07454) Advantage (07523) Bio-Scan Bio-Gen 5 (07453) (61167) Cascade Medical CheckMate Plus Blood TECH-CO Visual HCG Pregnancy Test Bio-Scan Bio-Gen 6 (07452) Glucose System (10236) (61099) Bio-Scan Bio-Gen 7 (07451) Clinical Diagnostics GLUCOchek Visual TECO One-Step Pregnancy Test (61146) Bio-Scan Bio-Gen 8 (07450) The Mentholatum Co. BODYWISE Test Strips (10272) Bio-Scan Bio-Glu Ketone (07457) Pregnancy Test (61160) Diagnostic Solutions Quick Check One Bld Bio-Scan Bio-Glucose (07459) True Medix Beta Spec hCG (61139) Glucose Test Strips (13300) Bio-Scan Bio-Ketone (07458) Unipath Clearview HCG DUO (64031) Diagnostic Solutions Relief Plus Blood BioScan Reagent Strips (07541) Unipath Clearview HCG Test (64024) Glucose Test Strips (13299) Boehringer Mannheim Chemstrip 10 S–UA HemoCue B-Glucose System (25112) SPECIALITY/SUBSPECIALITY: General (07519) Home Diagnostics ULTRA+ Blood Glucose Chemistry Eiken UROPAPER Eiken 5 (16049) Reagent Strips (25154) Eiken UROPAPER Eiken 6B (16059) ANALYTE: Fecal Occult Blood (9191) Lifescan ONE TOUCH IIB Blood Glucose Eiken UROPAPER Eiken 7 (16053) TEST SYSTEM, ASSAY OR Meter (37067) Eiken UROPAPER Eiken 8 (16052) EXAMINATION: Polymer Technology ‘‘655’’ Glucose Test Eiken UROPAPER Eiken AG (16050) Aerscher HemaPrompt (04544) Strips (49094) Eiken UROPAPER Eiken GK(16068) Propper Super Seracult (49096) SPECIALITY/SUBSPECIALITY: Hematology Eiken UROPAPER Eiken GP (16069) ANALYTE: Glucose Monitoring Devices Eiken UROPAPER Eiken HAG (16051) (FDA Cleared/Home Use) (9221) ANALYTE: Spun Microhematocrit (9581) Eli Lilly Tes-Tape (Glucose Enzymatic Test TEST SYSTEM, ASSAY OR TEST SYSTEM, ASSAY OR Strip) (16030) EXAMINATION: EXAMINATION: TECO Diagnostics Urine Reagent Strips 3 Ames Glucometer ELITE Blood Glucose Separation Technology STI HemataSTAT II (61153) Test Strips (04521) (58311) Ames Glucometer ELITE Diabetes Care Separation Technology STI HemataSTAT [FR Doc. 95–11653 Filed 5–12–95; 8:45 am] System (04499) Model C70 (58309) BILLING CODE 4160±17±M