FIAX TEST KIT FOR TOBRAMYCIN QUANTITA
Device Facts
| Record ID | K801308 |
|---|---|
| Device Name | FIAX TEST KIT FOR TOBRAMYCIN QUANTITA |
| Applicant | Intl. Diagnostic Technology |
| Product Code | LCR · Clinical Toxicology |
| Decision Date | Jun 20, 1980 |
| 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.
