21 CFR § 862.3645 Clinical Chemistry and Clinical Toxicology Devices

§ 862.3645 Neuroleptic drugs radioreceptor assay test system.

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

⚠ 2 pending changes to Part 862

(a) Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.

(b) Classification. Class II.

← § 862.3640 Morphine test system.§ 862.3650 Opiate test system. →