Data / Medical devices / Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine / United States
FDA-registered makers of Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine in the United States: 17 establishments
17 establishments in the United States are registered with the FDA to make Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine (product code KLI). 10 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.
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- Device
- Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- Product code
- KLI
- Country
- United States
Makers of Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 3 | August 22, 2003 | 0 | 0 | 0 | api.fda.gov |
| Alfa Wassermann | West Caldwell, NJ, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 2 | August 14, 2013 | 0 | 0 | 0 | api.fda.gov |
| Monobind, Inc. | Lake Forest, CA, United States | Manufacturer | 2 | August 22, 2003 | 0 | 0 | 0 | api.fda.gov |
| Microgenics Corporation | Fremont, CA, United States | Manufacturer | 2 | December 9, 1994 | 0 | 0 | 0 | api.fda.gov |
| Astoria-Pacific, Inc. | Clackamas, OR, United States | Complaint file establishment, Manufacturer | 1 | October 6, 1997 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Chaska, MN, United States | Manufacturer | 1 | December 9, 2002 | 0 | 2 | 0 | api.fda.gov |
| Hemagen Diagnostics, Inc. | Baltimore, MD, United States | Manufacturer | 1 | January 27, 1989 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | December 18, 1996 | 0 | 3 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer, Specification developer | 1 | February 26, 2009 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | February 26, 2009 | 0 | 1 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Specification developer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CTK Biotech, Inc. | Poway, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| DIAMOND DIAGNOSTICS Inc | Holliston, MA, United States | Contract manufacturer | 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 | |
| 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.