DNO · Hemagglutination Inhibition, Gentamicin
Clinical Toxicology · 21 CFR 862.3450 · Class 2
Overview
| Product Code | DNO |
|---|---|
| Device Name | Hemagglutination Inhibition, Gentamicin |
| Regulation | 21 CFR 862.3450 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.
Classification Rationale
Class II.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K964009 | IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS | Beckman Instruments, Inc. | Feb 11, 1997 | SESE |
Top Applicants
- Beckman Instruments, Inc. — 1 clearance
