LPX · Radioceptor Assay, Neuroleptic Drugs
Clinical Toxicology · 21 CFR 862.3645 · Class 2
Overview
| Product Code | LPX |
|---|---|
| Device Name | Radioceptor Assay, Neuroleptic Drugs |
| Regulation | 21 CFR 862.3645 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
