21 CFR 862.3645 - Neuroleptic drugs radioreceptor assay test system.

§ 862.3645 Neuroleptic drugs radioreceptor assay test system.
(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.

Title 21 published on 2013-04-01

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