Data / Medical devices / System, Test, Thyroid Autoantibody / United States
FDA-registered makers of System, Test, Thyroid Autoantibody in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make System, Test, Thyroid Autoantibody (product code JZO). 10 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
- System, Test, Thyroid Autoantibody
- Product code
- JZO
- Country
- United States
Makers of System, Test, Thyroid Autoantibody in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 6 | October 17, 2025 | 0 | 1 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 3 | October 17, 2025 | 0 | 3 | 0 | api.fda.gov |
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer, Repackager or relabeler | 3 | March 22, 2004 | 0 | 0 | 0 | api.fda.gov |
| Fisher Diagnostics | Middletown, VA, United States | Contract manufacturer, Manufacturer | 2 | July 18, 2006 | 0 | 0 | 0 | api.fda.gov |
| Gold Standard Diagnostics, LLC | Davis, CA, United States | Repackager or relabeler, Specification developer | 2 | February 2, 1999 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Chaska, MN, United States | Contract manufacturer, Manufacturer | 1 | September 26, 2023 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Complaint file establishment, Specification developer | 1 | June 30, 1995 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer, Manufacturer for export, Repackager or relabeler | 1 | July 20, 1976 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Athens, OH, United States | Complaint file establishment, Manufacturer, Manufacturer for export | 1 | May 18, 2010 | 0 | 0 | 0 | api.fda.gov |
| Theratest Laboratories, Inc. | Lombard, IL, United States | Manufacturer | 1 | September 3, 2009 | 0 | 0 | 0 | api.fda.gov |
| Calbiotech, Inc. | El Cajon, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epitope Diagnostics, Inc. | San Diego, 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 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.