COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA
Device Facts
| Record ID | K843828 |
|---|---|
| Device Name | COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product Code | LFW · Clinical Toxicology |
| Decision Date | Feb 1, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3900 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A tobramycin test system is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.
