Electronic Code of Federal Regulations
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e-CFR data is current as of April 8, 2021 |
Title 21 → Chapter I → Subchapter H → Part 862 → Subpart D → §862.3645 |
Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart D—Clinical Toxicology Test Systems
§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.