COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS
Device Facts
| Record ID | K945523 |
|---|---|
| Device Name | COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product Code | LCQ · Clinical Toxicology |
| Decision Date | Mar 9, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3450 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.
