MACRO-VUE CARD TEST
Device Facts
| Record ID | K810597 |
|---|---|
| Device Name | MACRO-VUE CARD TEST |
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| Product Code | KLB · Clinical Toxicology |
| Decision Date | Mar 17, 1981 |
| 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.
