DJB · Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
Clinical Toxicology · 21 CFR 862.3450 · Class 2
Overview
| Product Code | DJB |
|---|---|
| Device Name | Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep. |
| 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 (19 of 19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K832792 | AMES TDA SISOMICIN TEST-CONTROL SERUM | Miles Laboratories, Inc. | Sep 29, 1983 | SESE |
| K831210 | GENTAMICIN TEST PACK-ACA | E.I. Dupont DE Nemours & Co., Inc. | May 25, 1983 | SESE |
| K821669 | AMES TDA GENTAMICIN TEST | Miles Laboratories, Inc. | Dec 15, 1982 | SESE |
| K812394 | MRI GENTAMICIN RIA KIT | Microanalytic Research, Inc. | Sep 8, 1981 | SESE |
| K811844 | COAT-A-COUNT GENTAMICIN RIA KIT | Diagnostic Products Corp. | Jul 10, 1981 | SESE |
| K800537 | GAMMA STICK GENTAMICIN RIA KIT | Alpha Gamma Laboratory | Apr 24, 1980 | SESE |
| K791770 | QUANTIMUNE GENTAMICIN RIA GENTAMICIN | Bio-Rad | Oct 17, 1979 | SESE |
| K791547 | FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY | Bio-Rad | Oct 12, 1979 | SESE |
| K782049 | BIOASSAY SYSTEM, MS-2 SERUM | Abbott Laboratories | Aug 28, 1979 | SESE |
| K790584 | AMES TDA/GENTGMICIN | Miles Laboratories, Inc. | Jun 15, 1979 | SESE |
| K790829 | EMIT GENTAMICIN ASSAY | Syva Co. | May 15, 1979 | SESE |
| K782126 | RIA KIT, SISOMICIN | Diagnostic Products Corp. | Feb 15, 1979 | SESE |
| K781674 | MACRO-VUE TEST, GENTAMICIN | Bd Becton Dickinson Vacutainer Systems Preanalytic | Nov 15, 1978 | SESE |
| K780516 | GENTAMICIN RIA KIT | Antibodies, Inc. | Apr 28, 1978 | SESE |
| K772116 | AMINOGLYCOSIDE TEST SYSTEM | Nichols Institute Diagnostics | Apr 28, 1978 | SESE |
| K780323 | QUANTITOPE 125-I GENTAMICIN RIA KIT | Kallestad Laboratories, Inc. | Mar 17, 1978 | SESE |
| K772425 | RIANEN GENTAMICIN RIA KIT | New England Nuclear | Jan 5, 1978 | SESE |
| K761157 | AMINOGLYCOSIDE (125I) RIA KIT | Diagnostic Products Corp. | Mar 1, 1977 | SESE |
| K760068 | KIT, RIA, GENTAMICIN SULF. | New England Nuclear | Jul 20, 1976 | SESE |
Top Applicants
- Diagnostic Products Corp. — 3 clearances
- Miles Laboratories, Inc. — 3 clearances
- Bio-Rad — 2 clearances
- New England Nuclear — 2 clearances
- Abbott Laboratories — 1 clearance
