DON · Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.
Clinical Toxicology · 21 CFR 862.3320 · Class 2
Overview
| Product Code | DON |
|---|---|
| Device Name | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep. |
| Regulation | 21 CFR 862.3320 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.
Classification Rationale
Class II.
Recent Cleared Devices (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K902861 | CIBA CORNING ACS DIGOXIN IMMUNOASSAY | Ciba Corning Diagnostics Corp. | Sep 10, 1990 | SESE |
| K881679 | CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY | Ciba Corning Diagnostics Corp. | Jul 8, 1988 | SESE |
| K840461 | MAGIC 125I DIGOXIN RADIOIMMUNOASSAY | Corning Medical & Scientific | Mar 23, 1984 | SESE |
| K830533 | PHASE II DIGOXIN RADIOIMMUNOASSAY KIT | Medical & Scientific Designs, Inc. | Apr 5, 1983 | SESE |
| K822053 | ZETAPHASE-DIG | Biological & Diagnostic Products | Jul 27, 1982 | SESE |
| K821000 | ENZYMUNE-TEST DIGOXIN | Icl Scientific | Apr 26, 1982 | SESE |
| K810296 | DIGOXIN RIA ASSAY | Ria Diagnostics | Feb 19, 1981 | SESE |
| K803075 | DIGOXIN RIABEAD DIAGNOSTIC KIT | Abbott Laboratories | Dec 22, 1980 | SESE |
| K791549 | TECHNICON STAR SYSTEM | Technicon Instruments Corp. | Sep 27, 1979 | SESE |
| K781660 | RIA, DIGOXIN | E. R. Squibb & Sons, Inc. | Oct 24, 1978 | SESE |
| K780475 | DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT | Burroughs Wellcome Co. | Apr 24, 1978 | SESE |
| K780207 | LIQUISOL DIGOXIN RIA TEST KIT | Damon Corp. | Feb 23, 1978 | SESE |
| K772422 | QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA | Bio-Rad | Feb 13, 1978 | SESE |
| K772098 | DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS | Bd Becton Dickinson Vacutainer Systems Preanalytic | Dec 20, 1977 | SESE |
| K771255 | CEBTRIA DIGOXIN RIA | Union Carbide Corp. | Aug 25, 1977 | SESE |
| K770269 | CAMMADISK DIGOXIN | Burroughs Wellcome Co. | Mar 16, 1977 | SESE |
| K760800 | SPAC DIGOXIN KIT | Mallinckrodt Critical Care | Nov 1, 1976 | SESE |
Top Applicants
- Burroughs Wellcome Co. — 2 clearances
- Ciba Corning Diagnostics Corp. — 2 clearances
- Abbott Laboratories — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Bio-Rad — 1 clearance
