COBAS FP REAGENTS FOR CARBAMAZEPINE
Device Facts
| Record ID | K850807 |
|---|---|
| Device Name | COBAS FP REAGENTS FOR CARBAMAZEPINE |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product Code | KLT · Clinical Toxicology |
| Decision Date | Mar 22, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3645 |
| Device Class | Class 2 |
Regulatory Classification
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.
