Food and Drug Administration, HHS § 862.3650
monitoring levels of lidocaine to en- tions in methadone maintenance treat- sure appropriate therapy. ment. (b) Classification. Class II. (b) Classification. Class II.
§ 862.3560 Lithium test system. § 862.3630 Methaqualone test system. (a) Identification. A lithium test sys- (a) Identification. A methaqualone tem is a device intended to measure test system is a device intended to lithium (from the drug lithium car- measure methaqualone, a hypnotic and bonate) in serum or plasma. Measure- sedative drug, in urine. Measurements ments of lithium are used to assure obtained by this device are used in the that the proper drug dosage is adminis- diagnosis and treatment of methaqua- tered in the treatment of patients with lone use or overdose. mental disturbances, such as manic-de- (b) Classification. Class II. pressive illness (bipolar disorder). § 862.3640 Morphine test system. (b) Classification. Class II. (a) Identification. A morphine test § 862.3580 Lysergic acid diethylamide system is a device intended to measure (LSD) test system. morphine, an addictive narcotic pain- (a) Identification. A lysergic acid relieving drug, and its analogs in diethylamide (LSD) test system is a serum, urine, and gastric contents. device intended to measure lysergic Measurements obtained by this device acid diethylamide, a hallucinogenic are used in the diagnosis and treat- drug, in serum, urine, and gastric con- ment of morphine use or overdose and tents. Measurements obtained by this in monitoring levels of morphine and device are used in the diagnosis and its analogs to ensure appropriate ther- treatment of LSD use or overdose. apy. (b) Classification. Class II. (b) Classification. Class II. § 862.3645 Neuroleptic drugs § 862.3600 Mercury test system. radioreceptor assay test system. (a) Identification. A mercury test sys- (a) Identification. A neuroleptic drugs tem is a device intended to measure radioceptor assay test system is a de- mercury, a heavy metal, in human vice intended to measure in serum or specimens. Measurements obtained by plasma the dopamine receptor blocking this device are used in the diagnosis activity of neuroleptic drugs and their and treatment of mercury poisoning. active metabolites. A neuroleptic drug (b) Classification. Class I. has anti-psychotic action affecting principally psychomotor activity, is § 862.3610 Methamphetamine test sys- generally without hypnotic effects, and tem. is a tranquilizer. Measurements ob- (a) Identification. A methamphet- tained by this device are used to aid in amine test system is a device intended determining whether a patient is tak- to measure methamphetamine, a cen- ing the prescribed dosage level of such tral nervous system stimulating drug, drugs. in serum, plasma, and urine. Measure- (b) Classification. Class II. ments obtained by this device are used in the diagnosis and treatment of § 862.3650 Opiate test system. methamphetamine use or overdose. (a) Identification. An opiate test sys- (b) Classification. Class II. tem is a device intended to measure any of the addictive narcotic pain-re- § 862.3620 Methadone test system. lieving opiate drugs in blood, serum, (a) Identification. A methadone test urine, gastric contents, and saliva. An system is a device intended to measure opiate is any natural or synthetic drug methadone, an addictive narcotic pain- that has morphine-like relieving drug, in serum and urine. pharmocological actions. The opiates Measurements obtained by this device include drugs such as morphine, mor- are used in the diagnosis and treat- phine glucoronide, heroin, codeine, ment of methadone use or overdose and nalorphine, and meperedine. Measure- to determine compliance with regula- ments obtained by this device are used
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