21 CFR § 862.3660 Clinical Chemistry and Clinical Toxicology Devices

§ 862.3660 Phenobarbital test system.

Current through Sep 8, 2026 · Read all of Part 862

⚠ 2 pending changes to Part 862

(a) Identification. A phenobarbitol test system is a device intended to measure phenobarbital, an antiepileptic and sedative-hypnotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy.

(b) Classification. Class II.

← § 862.3652 Organophosphate test system.§ 862.3670 Phenothiazine test system. →