Radioimmunoassay, Digoxin (125-I)
FDA product code LCS · Class II (moderate risk) · 21 CFR 862.3320 · Clinical Toxicology
15510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Pharmacia, Inc. 1
- Sorin Biomedica, Fiat, USA, Inc. 1
- E. R. Squibb & Sons, Inc. 1
- Technia Diagnostics , Ltd. 1
- Amersham Corp. 1
- M.A. Bioproducts 1
- Pcl-Ria, Inc. 1
- Antibodies, Inc. 1
- Abbott Laboratories 1
- Coulter Electronics, Inc. 1
- Sclavo, Inc. 1
- Cyberfluor, Inc. 1
- Innotron of Oregon, Inc. 1
- Seradyn, Inc. 1
- Monobind 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K922353 | Digoxin Coated Tube RiaLCS · Traditional | Monobind | 08/24/1992SE |
| K913562 | QMS - DigoxinLCS · Traditional | Seradyn, Inc. | 08/30/1991SE |
| K895828 | Innofluor Digoxin Reagent SetLCS · Traditional | Innotron of Oregon, Inc. | 10/30/1989SE |
| K884707 | Fiagen Digoxin Time-Resolved Fluoroimmunoassay KitLCS · Traditional | Cyberfluor, Inc. | 01/17/1989SE |
| K874748 | Immpulse Digoxin Assay ReagentsLCS · Traditional | Sclavo, Inc. | 02/19/1988SE |
| K864802 | Dart Digoxin AssayLCS · Traditional | Coulter Electronics, Inc. | 02/12/1987SE |
| K820154 | TDX DigoxinLCS · Traditional | Abbott Laboratories | 02/05/1982SE |
| K812749 | Ultra-DigLCS · Traditional | Antibodies, Inc. | 10/19/1981SE |
| K803047 | I-125 Labeled DigoxinLCS · Traditional | Pcl-Ria, Inc. | 12/22/1980SE |
| K801490 | Digoxin Eia KitLCS · Traditional | M.A. Bioproducts | 07/14/1980SE |
| K801413 | Amerlex Digoxin Ria KitLCS · Traditional | Amersham Corp. | 07/08/1980SE |
| K801202 | Digoxin Radioimmunoassay KitLCS · Traditional | Technia Diagnostics , Ltd. | 06/20/1980SE |
| K800997 | Digoxin Clasp Ria KitLCS · Traditional | E. R. Squibb & Sons, Inc. | 05/08/1980SE |
| K800773 | Digoctk 125LCS · Traditional | Sorin Biomedica, Fiat, USA, Inc. | 04/24/1980SE |
| K770322 | Phaldebas Digoxin RiaLCS · Traditional | Pharmacia, Inc. | 04/05/1977SE |