KZX · Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Tobramycin
Clinical Toxicology · 21 CFR 862.3900 · Class 2
Overview
| Product Code | KZX |
|---|---|
| Device Name | Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Tobramycin |
| Regulation | 21 CFR 862.3900 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
