<<

Food and Drug Administration, HHS § 862.3660

§ 862.3580 Lysergic acid diethylamide § 862.3640 test system. (LSD) test system. (a) Identification. A morphine test (a) Identification. A lysergic acid system is a device intended to measure diethylamide (LSD) test system is a morphine, an addictive pain- device intended to measure lysergic relieving drug, and its analogs in acid diethylamide, a hallucinogenic serum, urine, and gastric contents. drug, in serum, urine, and gastric con- Measurements obtained by this device tents. Measurements obtained by this are used in the diagnosis and treat- device are used in the diagnosis and ment of morphine use or overdose and treatment of LSD use or overdose. in monitoring levels of morphine and (b) Classification. Class II. its analogs to ensure appropriate ther- apy. § 862.3600 Mercury test system. (b) Classification. Class II. (a) Identification. A mercury test sys- § 862.3645 Neuroleptic drugs tem is a device intended to measure radioreceptor assay test system. mercury, a heavy metal, in human (a) Identification. A neuroleptic drugs specimens. Measurements obtained by radioceptor assay test system is a de- this device are used in the diagnosis vice intended to measure in serum or and treatment of . plasma the dopamine receptor blocking (b) Classification. Class I. activity of neuroleptic drugs and their active metabolites. A neuroleptic drug § 862.3610 test sys- has anti-psychotic action affecting tem. principally psychomotor activity, is (a) Identification. A methamphet- generally without hypnotic effects, and amine test system is a device intended is a tranquilizer. Measurements ob- to measure methamphetamine, a cen- tained by this device are used to aid in tral nervous system stimulating drug, determining whether a patient is tak- in serum, plasma, and urine. Measure- ing the prescribed dosage level of such ments obtained by this device are used drugs. in the diagnosis and treatment of (b) Classification. Class II. methamphetamine use or overdose. § 862.3650 test system. (b) Classification. Class II. (a) Identification. An opiate test sys- § 862.3620 test system. tem is a device intended to measure any of the addictive narcotic pain-re- (a) Identification. A methadone test lieving opiate drugs in blood, serum, system is a device intended to measure urine, gastric contents, and saliva. An methadone, an addictive narcotic pain- opiate is any natural or synthetic drug relieving drug, in serum and urine. that has morphine-like Measurements obtained by this device pharmocological actions. The are used in the diagnosis and treat- include drugs such as morphine, mor- ment of methadone use or overdose and phine glucoronide, , , to determine compliance with regula- nalorphine, and meperedine. Measure- tions in methadone maintenance treat- ments obtained by this device are used ment. in the diagnosis and treatment of opi- (b) Classification. Class II. ate use or overdose and in monitoring the levels of opiate administration to § 862.3630 Methaqualone test system. ensure appropriate therapy. (a) Identification. A methaqualone (b) Classification. Class II. test system is a device intended to § 862.3660 Phenobarbital test system. measure methaqualone, a hypnotic and sedative drug, in urine. Measurements (a) Identification. A phenobarbitol obtained by this device are used in the test system is a device intended to diagnosis and treatment of methaqua- measure phenobarbital, an lone use or overdose. antiepileptic and sedative-hypnotic drug, in human specimens. Measure- (b) Classification. Class II. ments obtained by this device are used

217

VerDate May<04>2004 11:27 May 12, 2004 Jkt 203071 PO 00000 Frm 00217 Fmt 8010 Sfmt 8010 Y:\SGML\203071T.XXX 203071T