Data / Medical devices / Radioimmunoassay, Free Thyroxine / United States
FDA-registered makers of Radioimmunoassay, Free Thyroxine in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Radioimmunoassay, Free Thyroxine (product code CEC). 9 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 3, 2026.
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- Device
- Radioimmunoassay, Free Thyroxine
- Product code
- CEC
- Country
- United States
Makers of Radioimmunoassay, Free Thyroxine 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 | Complaint file establishment, Manufacturer, Specification developer | 3 | November 26, 2014 | 0 | 1 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Chaska, MN, United States | Manufacturer | 2 | March 6, 2024 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 2 | September 13, 2013 | 0 | 1 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 1 | April 5, 2002 | 0 | 0 | 0 | api.fda.gov |
| Monobind, Inc. | Lake Forest, CA, United States | Manufacturer, Manufacturer for export | 1 | April 5, 2002 | 0 | 0 | 0 | api.fda.gov |
| MP Biomedicals Diagnostics Division | Solon, OH, United States | Manufacturer | 1 | January 12, 1983 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | March 18, 1997 | 0 | 0 | 0 | api.fda.gov |
| Qualigen, Inc. | Carlsbad, CA, United States | Manufacturer | 1 | July 3, 2003 | 0 | 1 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 1 | September 13, 2013 | 0 | 0 | 0 | api.fda.gov |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immunocentrix Corporation | Canoga Park, CA, United States | Manufacturer for export | 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 |
Updated November 3, 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.