dose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.

(b) Classification. Class II.

§ 862.3380 Ethosuximide test system.

(a) Identification. An ethosuximide test system is a device intended to measure ethosuximide, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of ethosuximide overdose and in monitoring levels of ethosuximide to ensure appropriate therapy.

(b) Classification. Class II.

§ 862.3450 Gentamicin test system.

(a) Identification. A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therару.

(b) Classification. Class II.

§ 862.3520 Kanamycin test system.

(a) Identification. A kanamycin test system is a device intended to measure kanamycin, an antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of kanamycin overdose and in monitoring levels of kanamycin to ensure appropriate therapy. (b) Classification. Class II.

§ 862.3550 Lead test system.

(a) Identification. A lead test system is a device intended to measure lead, a heavy metal, in blood and urine. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning.

(b) Classification. Class II.

§ 862.3555 Lidocaine test system.

(a) Identification. A lidocaine test system is a device intended to measure lidocaine, an antiarrythmic and anticonvulsant drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of lidocaine overdose or in monitoring levels of lidocaine to ensure appropriate therapy.

(b) Classification. Class II.

§ 862.3560 Lithium test system.

(a) Identification. A lithium test system is a device intended to measure lithium (from the drug lithium carbonate) in serum or plasma. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder). (b) Classification. Class II.

$862.3580 Lysergic acid diethylamide (LSD) test system.

(a) Identification. A lysergic acid diethylamide (LSD) test system is a device intended to measure lysergic acid diethylamide, a hallucinogenic drug, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of LSD use or overdose. (b) Classification. Class II.

§ 862.3600 Mercury test system.

(a) Identification. A mercury test system is a device intended to measure mercury, a heavy metal, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of mercury poisoning. (b) Classification. Class I.

§ 862.3610 Methamphetamine test system.

(a) Identification. A

methamphet

amine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose. (b) Classification. Class II.

§ 862.3620 Methadone test system.

(a) Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic painrelieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.

(b) Classification. Class II.

§ 862.3650 Opiate test system.

(a) Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.