LBZ · Enzyme Immunoassay, Quinidine
Clinical Toxicology · 21 CFR 862.3320 · Class 2
Overview
| Product Code | LBZ |
|---|---|
| Device Name | Enzyme Immunoassay, Quinidine |
| 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 (20 of 27)
Showing 20 most recent of 27 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K052826 | QMS QUINIDINE. QMS QUINIDINE CALIBRATORS | Seradyn, Inc. | Dec 23, 2005 | SESE |
| K032332 | ROCHE ONLINE TDM QUINIDINE | Roche Diagnostics Corp. | Jan 12, 2004 | SESE |
| K011605 | EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229 | Syva Co., Dade Behring, Inc. | Jun 12, 2001 | SESE |
| K964116 | QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | Bayer Corp. | Dec 24, 1996 | SESE |
| K964212 | QUINIDINE ENZYME IMMUNOASSAY | Diagnostic Reagents, Inc. | Dec 18, 1996 | SESE |
| K955568 | INNOFLUOR QUINIDINE ASSAY SYSTEM | Oxis Intl., Inc. | Apr 4, 1996 | SESE |
| K941440 | COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS | Roche Diagnostic Systems, Inc. | Jul 6, 1994 | SESE |
| K922913 | EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS | Syva Co. | Aug 24, 1992 | SESE |
| K904990 | EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS | Syva Co. | Feb 4, 1991 | SESE |
| K900705 | MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR | Innotron of Oregon, Inc. | Apr 12, 1990 | SESE |
| K892208 | INNOFLUOR(TM) QUINIDINE REAGENT SET | Innotron of Oregon, Inc. | Jun 9, 1989 | SESE |
| K872175 | TDXR FLECAINIDE | Abbott Laboratories | Aug 13, 1987 | SESE |
| K864607 | EASY-TEST QUINIDINE ITEM NO. 67---/95 | Em Diagnostic Systems, Inc. | Jan 8, 1987 | SESE |
| K862214 | EMIT QUINIDINE ASSAY | Syva Co. | Jun 27, 1986 | SESE |
| K860049 | DETERMINATION OF QUINIDINE | Clinical Data, Inc. | Jan 22, 1986 | SESE |
| K850808 | COBAS FP REAGENTS FOR QUINIDINE | Roche Diagnostic Systems, Inc. | Mar 25, 1985 | SESE |
| K843237 | STRATUS QUINIDINE FLUOROMETRIC ENZYME | American Dade | Sep 12, 1984 | SESE |
| K842713 | TDX DISOPYRAMIDE | Abbott Laboratories | Aug 29, 1984 | SESE |
| K840596 | QUINIDINE ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | Apr 4, 1984 | SESE |
| K832493 | QUINIDINE FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | Sep 12, 1983 | SESE |
Top Applicants
- Syva Co. — 7 clearances
- Abbott Laboratories — 3 clearances
- Innotron of Oregon, Inc. — 2 clearances
- Roche Diagnostic Systems, Inc. — 2 clearances
- American Dade — 1 clearance
