Data / Medical devices / Enzyme Immunoassay, Digoxin / United States
FDA-registered makers of Enzyme Immunoassay, Digoxin in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Enzyme Immunoassay, Digoxin (product code KXT). 6 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Enzyme Immunoassay, Digoxin
- Product code
- KXT
- Country
- United States
Makers of Enzyme Immunoassay, Digoxin in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer, Specification developer | 6 | April 7, 2010 | 0 | 2 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 2 | July 16, 2021 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Specification developer | 1 | October 14, 1998 | 0 | 1 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Chaska, MN, United States | Manufacturer | 1 | January 13, 1993 | 0 | 0 | 0 | api.fda.gov |
| Microgenics Corporation | Fremont, CA, United States | Contract manufacturer, Manufacturer | 1 | October 24, 2002 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc | East Walpole, MA, United States | Manufacturer | 1 | July 16, 2021 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Monobind, Inc. | Lake Forest, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Supplies & Technology, Inc. | Doral, FL, United States | Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.