21 CFR Part 862 · Clinical Chemistry and Clinical Toxicology Devices

§ 862.3645 Neuroleptic drugs radioreceptor assay test system

Subpart D - Clinical Toxicology Test Systems Official text on eCFR Amendment history

(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.

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Amendment history

Federal Register documents that created or amended this section.