{"data":{"id":"us/21-cfr-862.3645","jurisdiction":"us","citation":"21 CFR 862.3645","heading":"Neuroleptic drugs radioreceptor assay test system.","body":"(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.\n(b) Classification. Class II.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES","Subpart D—Clinical Toxicology Test Systems"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"28a81ab93dedb74fec03b2b6a41aa245baf60c11e918cb6153e9c2e966819da5","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.3640","next":"us/21-cfr-862.3650"},"notice":"GroundRules: Original legal text. Not legal advice."}