DOG · Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol
Clinical Toxicology · 21 CFR 862.3320 · Class 2
Overview
| Product Code | DOG |
|---|---|
| Device Name | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol |
| 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 (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K810477 | DCA DIGOX-SYN RIA TEST | Diagnostic Corp. of America | Mar 11, 1981 | SESE |
| K803045 | IMMU-TRACE DIGOXIN (125I) RADIOIMMUN. | American Dade | Dec 22, 1980 | SESE |
| K781335 | DIGOXIN RIA (PEG) KIT | Ortho Diagnostics, Inc. | Aug 31, 1978 | SESE |
| K760709 | EMIT DIGOKIN ASSAY | Syva Co. | Oct 21, 1976 | SESE |
| K760416 | DATA-TOPE SYSTEM DIGOXIN RIA | Dade, Baxter Travenol Diagnostics, Inc. | Aug 23, 1976 | SESE |
Top Applicants
- American Dade — 1 clearance
- Dade, Baxter Travenol Diagnostics, Inc. — 1 clearance
- Diagnostic Corp. of America — 1 clearance
- Ortho Diagnostics, Inc. — 1 clearance
- Syva Co. — 1 clearance
