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Code · CFR · Title 21 — Food and Drugs · Part 862 — Clinical Chemistry and Clinical Toxicology Devices · § 862.3645

§ 862.3645. Neuroleptic drugs radioreceptor assay test system.

77 words·~1 min read·/us/cfr/t21/s§ 862.3645·

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(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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