LCS · Radioimmunoassay, Digoxin (125-I)
Clinical Toxicology · 21 CFR 862.3320 · Class 2
Overview
| Product Code | LCS |
|---|---|
| Device Name | Radioimmunoassay, Digoxin (125-I) |
| 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 (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K922353 | DIGOXIN COATED TUBE RIA | Monobind | Aug 24, 1992 | SESE |
| K913562 | QMS - DIGOXIN | Seradyn, Inc. | Aug 30, 1991 | SESE |
| K895828 | INNOFLUOR DIGOXIN REAGENT SET | Innotron of Oregon, Inc. | Oct 30, 1989 | SESE |
| K884707 | FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT | Cyberfluor, Inc. | Jan 17, 1989 | SESE |
| K874748 | IMMPULSE DIGOXIN ASSAY REAGENTS | Sclavo, Inc. | Feb 19, 1988 | SESE |
| K864802 | DART DIGOXIN ASSAY | Coulter Electronics, Inc. | Feb 12, 1987 | SESE |
| K820154 | TDX DIGOXIN | Abbott Laboratories | Feb 5, 1982 | SESE |
| K812749 | ULTRA-DIG | Antibodies, Inc. | Oct 19, 1981 | SESE |
| K803047 | I-125 LABELED DIGOXIN | Pcl-Ria, Inc. | Dec 22, 1980 | SESE |
| K801490 | DIGOXIN EIA KIT | M.A. Bioproducts | Jul 14, 1980 | SESE |
| K801413 | AMERLEX DIGOXIN RIA KIT | Amersham Corp. | Jul 8, 1980 | SESE |
| K801202 | DIGOXIN RADIOIMMUNOASSAY KIT | Technia Diagnostics , Ltd. | Jun 20, 1980 | SESE |
| K800997 | DIGOXIN CLASP RIA KIT | E. R. Squibb & Sons, Inc. | May 8, 1980 | SESE |
| K800773 | DIGOCTK 125 | Sorin Biomedica, Fiat, USA, Inc. | Apr 24, 1980 | SESE |
| K770322 | PHALDEBAS DIGOXIN RIA | Pharmacia, Inc. | Apr 5, 1977 | SESE |
Top Applicants
- Abbott Laboratories — 1 clearance
- Amersham Corp. — 1 clearance
- Antibodies, Inc. — 1 clearance
- Coulter Electronics, Inc. — 1 clearance
- Cyberfluor, Inc. — 1 clearance
