COBAS-FP REAGENTS FOR VANCOMYCIN
Device Facts
| Record ID | K901759 |
|---|---|
| Device Name | COBAS-FP REAGENTS FOR VANCOMYCIN |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product Code | LEH · Clinical Toxicology |
| Decision Date | May 2, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3950 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.
