DPO · Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.
Clinical Toxicology · 21 CFR 862.3320 · Class 2
Overview
| Product Code | DPO |
|---|---|
| Device Name | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube 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 (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K914833 | IMMULITE DIGOXIN | Cirrus Diagnostics, Inc. | Nov 22, 1991 | SESE |
| K905719 | ECLIPSE ICA DIGOXIN | Biotope, Inc. | Jan 17, 1991 | SESE |
| K864449 | DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT | Canadian Bioclinical, Ltd. | Feb 2, 1987 | SESE |
| K833842 | RIA COAT DIGOXIN | Immuno Assay Corp. | Jan 17, 1984 | SESE |
| K832163 | SOPHEIA DIGOXIN EIA KIT | Diagnostic Products Corp. | Aug 12, 1983 | SESE |
| K830962 | IMMUCHEM COVALENT-COAT RIA KIT | Immuchem Corp. | May 4, 1983 | SESE |
| K811932 | COAT-A-COUNT DIGOXIN RIA | Diagnostic Products Corp. | Jul 23, 1981 | SESE |
| K811776 | KALLESTAD QUANTICOAT 125 DIGOXIN | Kallestad Laboratories, Inc. | Jul 10, 1981 | SESE |
| K800205 | RIA PHASE DIGOXIN | Boehringer Mannheim Corp. | Mar 19, 1980 | SESE |
| K791325 | AUTOPAK 12 DIGOXIN TEST DELIVERY SYSTEM | Micromedic Systems | Aug 16, 1979 | SESE |
| K791355 | VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT | Ventrex Laboratories, Inc. | Aug 10, 1979 | SESE |
| K771638 | IGOXIN SOLID PHASE RIA | Bd Becton Dickinson Vacutainer Systems Preanalytic | Oct 7, 1977 | SESE |
| K770365 | RADIOIMMUNOASSAY DIGOXIN TEST, IN VITRO | Travenol Laboratories, S.A. | Feb 24, 1977 | SESE |
| K770069 | DIGOXIN CLASP TM RIA KIT | E. R. Squibb & Sons, Inc. | Jan 18, 1977 | SESE |
Top Applicants
- Diagnostic Products Corp. — 2 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Biotope, Inc. — 1 clearance
- Boehringer Mannheim Corp. — 1 clearance
- Canadian Bioclinical, Ltd. — 1 clearance
