DNJ · Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep.
Clinical Toxicology · 21 CFR 862.3320 · Class 2
Overview
| Product Code | DNJ |
|---|---|
| Device Name | Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K771877 | DIGOXIN RIA KIT | Antibodies, Inc. | Oct 21, 1977 | SESE |
| K771533 | DIGOXIN RIA KIT | G.D. Searle and Co. | Aug 25, 1977 | SESE |
Top Applicants
- Antibodies, Inc. — 1 clearance
- G.D. Searle and Co. — 1 clearance
