DNL · Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.
Clinical Toxicology · 21 CFR 862.3320 · Class 2
Overview
| Product Code | DNL |
|---|---|
| Device Name | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second 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 (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K852343 | DIG RADIOIMMUNOASSAY TEST SYSTEM | M Nobird, Inc. | Jul 9, 1985 | SESE |
| K852291 | TIPSEP DIGOXIN RIA | Nuclear Diagnostics, Inc. | Jun 25, 1985 | SESE |
| K811212 | DIGOXIN (RIA) KIT | Immuno Assay Corp. | May 21, 1981 | SESE |
| K810966 | DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT | E. R. Squibb & Sons, Inc. | Apr 21, 1981 | SESE |
| K802841 | DIGOXIN RADIOIMMUNOASSAY KIT | American Diagnostic Corp. | Dec 18, 1980 | SESE |
| K781834 | TEST SET, 125 I-DIGOXIN | Wien Laboratories, Inc. | Jan 3, 1979 | SESE |
| K781495 | RIANEN ASSAY SYSTEM, 125I KIT | New England Nuclear | Sep 14, 1978 | SESE |
| K772110 | IN VITRO DIGOXIN RIA TEST | Clinical Assays, Inc. | Nov 22, 1977 | SESE |
Top Applicants
- American Diagnostic Corp. — 1 clearance
- Clinical Assays, Inc. — 1 clearance
- E. R. Squibb & Sons, Inc. — 1 clearance
- Immuno Assay Corp. — 1 clearance
- M Nobird, Inc. — 1 clearance
