DPB · Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.
Clinical Toxicology · 21 CFR 862.3320 · Class 2
Overview
| Product Code | DPB |
|---|---|
| Device Name | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal 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 (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K853021 | OPTIMATE DIGOXIN TEST | Miles Laboratories, Inc. | Aug 7, 1985 | SESE |
| K823014 | DIGOXIN KIT | Pcl-Ria, Inc. | Nov 1, 1982 | SESE |
| K821811 | 125I DIGOXIN RADIOIMMUNOASSAY KIT | Cambridge Medical Technology | Jul 2, 1982 | SESE |
| K820274 | DIGOXIN RADIOIMMUNOASSAY | American Diagnostic Corp. | Feb 23, 1982 | SESE |
| K792153 | DIGOXIN RADIOIMMUNOASSAY SYSTEM | Radioimmunoassay, Inc. | Nov 13, 1979 | SESE |
| K790602 | RIA, DIGNXIN-125-I | Endocrine-Metabolic Center | Jul 30, 1979 | SESE |
| K790540 | RIA TEST KIT, CENTRIA DIGOXIN | Ventrex Laboratories, Inc. | Apr 23, 1979 | SESE |
| K772306 | 125I DIGOXIN TEST SET | Wien Laboratories, Inc. | Dec 22, 1977 | SESE |
| K771525 | 125 I DIGOXIN RIA KIT | Diagnostic Products Corp. | Oct 14, 1977 | SESE |
| K760883 | DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAY | Nuclear Medical Laboratories, Inc. | Nov 19, 1976 | SESE |
Top Applicants
- American Diagnostic Corp. — 1 clearance
- Cambridge Medical Technology — 1 clearance
- Diagnostic Products Corp. — 1 clearance
- Endocrine-Metabolic Center — 1 clearance
- Miles Laboratories, Inc. — 1 clearance
