Panels › Clinical Toxicology › Product code KXT · Class 2
Enzyme Immunoassay, Digoxin
Regulation 862.3320
0510(k)s in 12 months (85 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in KXT
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 5, 2017 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Digoxin (DIGXN) Flex reagent cartridge Terminated |
KXT | K093441 |
| Apr 18, 2013 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product. Terminated |
KXT | K093441 K112142 |
| Nov 21, 2008 | Abbott Diagnostic International, Ltd. AxSYM Digoxin II Reagent Pack, Disk Version 1. (3D53-01 or 3D53-02)
The AxSYM Digoxin II assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of digoxin, a cardiovascul Terminated |
KXT | K953718 |
| Nov 3, 2007 | Abbott Diagnostic International, Ltd. Abbott Diagnostic International, Ltd.-- AxSYM Digoxin III Reagent Pack, List (6L07-20), For In Vitro Diagnostic use. This reagent system is composed of one bottle of Digoxin-Alkaline Phosphatase Conj Terminated |
KXT | K061249 |
| Aug 29, 2007 | Abbott Diagnostic International, Ltd. Abbott AxSYM System Digoxin III Reagent Pack Terminated |
KXT | K061249 |
| Apr 13, 2007 | Roche Diagnostics Corp. Roche COBAS Integra DIG, Digoxin Reagent for use on the COBAS INTEGRA models 400, 400 plus, 700 and 800 analyzers, as well as, Cobas c 501 analyzer; Catalog Number 20737836322. Terminated |
KXT | K851032 |
| Mar 8, 2005 | Beckman Coulter Inc Access Immunoasay Systems Digoxin Reagent Terminated |
KXT | K925802 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.