KZW · Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Kanamycin
Clinical Toxicology · 21 CFR 862.3520 · Class 2
Overview
| Product Code | KZW |
|---|---|
| Device Name | Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Kanamycin |
| Regulation | 21 CFR 862.3520 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A kanamycin test system is a device intended to measure kanamycin, an antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of kanamycin overdose and in monitoring levels of kanamycin to ensure appropriate therapy.
Classification Rationale
Class II.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
