CLIA Waived Tests and CPT Codes

CLIA Waived Tests and CPT Codes

Waived Tests and CPT Codes This list is for informational purposes only and may not accurately represent current CMS CPT codes. Please verify your tests waived status and CPT code prior to implementing testing. Approved Test Name/Specific Test System Manufacturer CPT Code(s) Adenovirus AdenoPlus (human eye fluid) Rapid Pathogen Screening, Inc. 87809QW Quidel, AdenoPlus Test, Adeno Detector, Detecor Plus (Tear Fluid) Quidel Corporation 87809QW Quidel Corporation, QuickVue Adenoviral Conjunctivitis Test {Tear Quidel Corporation 87809QW Fluid} Rapid Pathogen Screening RPS Adeno Detector Rapid Pathogen Screening, Inc. 87809QW Aerobic/Anaerobic Organisms - Vaginal Genzyme Diagnostics OSOM BVBLUE Test Gryphus Diagnostics, LLC 87905QW Gryphus Diagnostics BVBlue Gryphus Diagnostics, LLC 87905QW OBGYN-Vph Vaginal Ph Screening Kit Teco Diagnostics Pending Aerobic/Anaerobic/Viral Panel - Respiratory FilmArray Respiratory Panel 2.0 EZ (RP EZ) (nasopharyngeal) Biofire Diagnostics, LLC Pending Albumin Abaxis Piccolo Blood Chem Analyzer WB (Chem 13, CMP, Renal) Abaxis, Inc 82040QW Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Abaxis, Inc. 82040QW Reagent Disc) Abaxis Piccolo xpress Chem Analyzer WB Abaxis, Inc 82040QW (Chem 13, CMP, Liver Panel Plus, Renal) Arkray SPOTCHEM EZ Chem Analyzer (WB) Polymedco, Inc 82040QW Genzyme Diag OSOM ImmunoDip (urinary alb) Genzyme Diagnostics 82040QW HemoCue Albumin 201 System (urinary albumin) HemoCue AB 82040QW TECO Diagnostics, Albumin Rapid Test Stick and Card Teco Diagnotics 82040QW Alanine Aminotransferase (ALT) Abaxis Piccolo Blood Chem Analyzer WB (CMP, Chem 6, Chem Abaxis, Inc 84460QW 13) Abaxis Piccolo Point Of Care Chemistry Analyzer (Lipid Panel Abaxis, Inc. 84460QW Reagent Disc) ALT Abaxis Piccolo xpress Chem Analyzer WB(CMP, Lipid Panel Plus, Abaxis, Inc 84460QW Liver Panel Plus, Chem 6, Chem 13) Alere Cholestech LDX (ALT)(WB) Alere, Inc 84466QW Arkray SPOTCHEM EZ Chem Analyzer (WB) Arkray, Inc. / Polymedco, Inc 84460QW Cholestech LDX Alanine Aminotransferase (ALT) Cholestech Corporation 84460QW Alkaline Phosphatase (ALP) Abaxis Piccolo Blood Chem Analyzer WB (CMP, Chem 13) Abaxis, Inc 84075QW Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Abaxis, Inc. 84075QW Reagent Disc) (WB) Abaxis Piccolo xpress Chem Analyzer WB (CMP, Chem 13, Liver Abaxis, Inc 84075QW Panel Plus) Akray SPOTCHEM EZ Chem Analyzer (WB) Polymedco, Inc 84075QW Amylase Abaxis Piccolo Blood Chem Analyzer WB (Chem 13) Abaxis, Inc 82150QW Abaxis Piccolo express Chemistry Analyzer WB (Liver Panel Plus, Abaxis, Inc 82150QW Chem 13) Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Abaxis, Inc. 82150QW Reagent Disc)(WB) DOH 681-018 May 2020 Page 1 of 61 Approved Test Name/Specific Test System Manufacturer CPT Code(s) Aspartate Aminotransferase (AST) Abaxis Piccolo Blood Chem Analyzer WB (Chem 6, Chem 13, Abaxis, Inc 84450QW CMP) Abaxis Piccolo Point Of Care Chemistry Analyzer (Liver Panel Abaxis, Inc. 84450QW Reagent Disc) AST (WB) Abaxis Piccolo xpress Chem Analyzer WB(Chem 6, Chem 13, Abaxis, Inc 84450QW CMP, Liver Panel Plus, Lipid Panel Plus) Arkray SPOTCHEM EZ Chem Analyzer (WB) Arkray, Inc. / Polymedco, Inc 84450QW Cholestech LDX Aspartate Aminotransferase Cholestech Corporation 84450QW B-Type Natriuretic Peptide (BNP) Biosite Triage Meter (WB) (BNP) Biosite Incorporated 83880QW Biosite Triage Meter Plus (WB)(BNP) Biosite Incorporated 83880QW Biosite Triage Meterpro (WB)(BNP) Biosite Incorporated 83880QW Basic Metabolic Panel (Calcium, Ionized) Abbott i-STAT CHEM8+ Cartridge WB I-STAT Corporation 80047QW Basic Metabolic Panel (Calcium, Total) Abaxis Piccolo Blood Chemistry Analyzer WB (Basic Metabolic Abaxis, Inc 80048QW Reagent Disc) Abaxis Piccolo xpress Chemistry Analyzer WB (Basic Metabolic Abaxis, Inc 80048QW Reagent Disc) Bilirubin, Total Abaxis Piccolo Blood Chem Analyzer WB (Chem 13, CMP) Abaxis, Inc 82247QW Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Abaxis, Inc. 82247QW Reagent Disc)(WB) Abaxis Piccolo xpress Chem Analyzer WB(Chem 13, CMP, Liver Abaxis, Inc 82247QW Panel Plus) Akray SPOTCHEM EZ Chem Analyzer (WB) Polymedco, Inc 82247QW Bladder Tumor Associated Antigen Alere NMP22 BladderChek Test Alere 86386QW BTA stat Test (for home use) Bion Diagnostic Sciences 86294QW LifeScan Status BTA Polymedco, Inc 86294QW Maritech BladderCheck Maritech, Inc. 86386QW BUN (Blood Urea Nitrogen) Abaxis Piccolo Blood Chemistry Analyzer (Chem 6 and 13 Panels, Abaxis, Inc. 84520QW CMP, BMP, Metlyte 8, Renal) Abaxis Piccolo xpress Chemistry Analyzer WB (Chem 6, 13, Kidney Abaxis, Inc. 84520QW Panels, CMP, BMP, Metlyte 8, Renal) Abbott i-STAT 6+ Cartridge (WB) i-STAT Corporation 84520QW Abbott i-STAT CHEM8+ Cartridge (WB) i-STAT Corporation 84520QW Arkray SPOTCHEM EZ Chem Analyzer (WB) Arkray, Inc. 84520QW Calcium Abaxis Piccolo Blood Chemistry Analyzer WB (Chem 13 Panel, Abaxis, Inc. 82310QW CMP, BMP, Renal) Abaxis Piccolo xpress Chemistry Analyzer WB (Chem 13 Panel, Abaxis, Inc. 82310QW CMP, BMP, Renal) Arkray SPOTCHEM EZ Chem Analyzer (WB) Polymedco, Inc 82310QW Calcium – Ionized Abbott i-STAT CHEM8+ Cartridge (WB) i-STAT Corporation 82330QW DOH 681-018 May 2020 Page 2 of 61 Approved Test Name/Specific Test System Manufacturer CPT Code(s) Carbon Dioxide (CO2) Abaxis Piccolo Blood Chemistry Analyzer (CMP, BMP, Electrolyte Abaxis, Inc 82374QW Discs, Metlyte 8, Renal) Abaxis Piccolo xpress Chemistry Analyzer (CMP, BMP, Electrolyte Abaxis, Inc 82374QW Discs, Metlyte 8, Renal) Abbott i-STAT CHEM8+ Cartridge (WB) i-STAT Corporation 82374QW Catalase Accutest Uriscreen Rapid UTI Screen Savyon Diagnostics 81007QW Uriscreen (for OTC use), urine Diatech Diagnostics 81007QW Chloride Abaxis Piccolo Blood Chemistry Analyzer (CMP, BMP, Electrolyte, Abaxis, Inc 82435QW Metlyte 8, Renal) Abaxis Piccolo xpress Chemistry Analyzer (CMP, BMP, Electrolyte, Abaxis, Inc 82435QW Metlyte 8, Renal) Abbott i-STAT 6+ Cartridge (WB) i-STAT Corporation 82435QW Abbott i-STAT CHEM8+ Cartridge (WB) i-STAT Corporation 82435QW Cholesterol Abaxis Piccolo xpress Chemistry Analyzer {capillary-finger stick} Abaxis, Inc 82465QW (Cholesterol) Abaxis Piccolo xpress Chemistry Analyzer WB (Lipid Panel, Lipid Abaxis, Inc 82465QW Panel Plus) Abaxis Piccolo Point of Care Chemistry Analyzer WB (Lipid Panel, Abaxis, Inc 82465QW Lipid Panel Plus) Accu-Check InstantPlus Cholesterol Test System Roche/Boehringer Mannheim 82465QW Accucheck Instant Plus Dual Testing System Roche Diagnostics 82465QW ACON Laboratories Inc., Mission Cholesterol Pro Monitoring ACON Laboratories, Inc. 82465QW System Advanced Care Cholesterol Measuring System Johnson & Johnson 82465QW Alere Cholestech LDX (cholesterol)(WB) Alere, Inc 82465QW Alere San Diego, Inc., Cholestech LDX {WB} Abbott 82465QW Arkray SPOTCHEM EZ Chem Analyzer (WB) Polymedco, Inc 82465QW Biomedix Inc Q Steps Biometer G/C Dual Monitoring System Biomedix, Inc. 82465QW ChemTrak AccuMeter Cholesterol Test System ChemTrak 82465QW Cholestech LDX (Must have software version 1.40 or above) Cholestech 82465QW ENA.C.T. Total Cholesterol & PDU ActiMed Laboratories, Inc 82465QW Germaine Laboratories Inc. AimStrip Tandem Lipid Profile and OSANG Healthcare Co., Ltd. 82465QW Glucose Measuring System Infopia USA LipidPro Infopia Co Ltd 82465QW Infopia USA LipidPro Professional Lipid Profile and Glucose Infopia Co Ltd 82465QW Measuring System Jant Pharmacal LipidPlus Lipid Profile and Glucose Measuring Infopia Co, Ltd 82465QW System KPI Healthcare Co., Ltd. CURO L5 Lipid Profile and Glucose OSANG Healthcare Co., Ltd. 82465QW Measuring System/Test Strips Lifestream Plus Cholesterol Monitor Lifestream Technologies 82465QW Lifestream Technologies Cholesterol Monitor Lifestream Technologies 82465QW DOH 681-018 May 2020 Page 3 of 61 Approved Test Name/Specific Test System Manufacturer CPT Code(s) Lifestream Technologies Personal Cholesterol Monitor for Lifestream Technologies, Inc. 82465QW cholesterol Mission Cholesterol Monitoring System and Mission Cholesterol Pro ACON Laboratories, INC 82465QW Monitoring System Polymer Technology Systems Bioscanner, Bioscanner Plus, and Polymer Technology Systems, 82465QW Bioscanner 2000 PTS Inc Polymer Technology Systems, Polymer Technology Systems MTM BioScanner 1000 82465QW Inc Polymer Technology Systems Cardiochek Plus, Cardiochek Home Use, Home Test System, and Cardiochek PA Analyzer test strips. 82465QW CardioChek Home Chol+HDL+Glu Test strips Polymer Technology Systems, -PTS Panels Lipid Panel test strips Inc 82947QW -CardioChek Home Lipid Panel test strips 82947QW Roche Diagnostics Accutrend Plus System WB Roche Diagnostics 82465QW SD Biosensor USA, Inc., SD LipidoCare (BT) Home Lipid Panel SD BIOSENSOR Pending Test Strip) SD Biosensor USA, Inc., SD LipidoCare (BT) Professional System SD BIOSENSOR Pending (SD LipidoCare Professional Lipid Panel Test Strip) Wako APOLOWAKO Analyzer Wako Chemicals USA 82465QW Complete Blood Count XW-100 Automated Hematology Analyzer for CLIA Waived Use (Hematocrit, Hemoglobin, Platelet Count, Red blood cell (RBC) Sysmex America, Inc Pending count, White blood cell (WBC) count, White blood cell differential) Comprehensive Metabolic Panel Abaxis Piccolo Blood Chemistry Analyzer WB (Comprehensive Abaxis, Inc 80053QW Metabolic Reagent Disc) Abaxis Piccolo xpress Chemistry Analyzer WB (Comprehensive Abaxis, Inc 80053QW Metabolic Reagent Disc) Creatine Kinase (CK) Abaxis Piccolo Blood Chemistry Analyzer WB (Metlyte 8 Disc) Abaxis, Inc 82550QW Abaxis Piccolo xpress Chemistry Analyzer WB (Metlyte 8 Disc) Abaxis,

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