COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS
Device Facts
| Record ID | K936130 |
|---|---|
| Device Name | COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product Code | LGQ · Clinical Toxicology |
| Decision Date | Mar 11, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3660 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A phenobarbitol test system is a device intended to measure phenobarbital, an antiepileptic and sedative-hypnotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy.
