21 CFR 862.3645 — Reagents, Test, Bromides
Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3645
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.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DLE | Reagents, Test, Bromides | 2 | 0 | 3rd Party |
| JKQ | Gold Chloride (Colorimetric), Bromide | 2 | 0 | 3rd Party |
| KLT | Enzyme Immunoassay, Carbamazepine | 2 | 56 | 3rd Party |
| LDB | U.V. Spectrometry, Carbamazepine | 2 | 0 | 3rd Party |
| LEG | Enzyme Immunoassay, Valproic Acid | 2 | 35 | 3rd Party |
| LGI | Fluorescence Polarization Immunoassay, Carbamazepine | 2 | 3 | 3rd Party |
| LPX | Radioceptor Assay, Neuroleptic Drugs | 2 | 0 | 3rd Party |
| POX | Enzyme Immunoassay, Oxcarbazepine Metabolite | 2 | 1 | 3rd Party |
