RIA KIT, KANAMYCIN
Device Facts
| Record ID | K782125 |
|---|---|
| Device Name | RIA KIT, KANAMYCIN |
| Applicant | Diagnostic Products Corp. |
| Product Code | KJI · Clinical Toxicology |
| Decision Date | Jan 10, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3520 |
| Device Class | Class 2 |
Regulatory Classification
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.