21 CFR 862.3520 — Radioimmunoassay, Kanamycin
Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3520
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KJI | Radioimmunoassay, Kanamycin | 2 | 6 | 3rd Party |
| KZW | Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Kanamycin | 2 | 0 | 3rd Party |
