Data / Medical devices / Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) / United States
FDA-registered makers of Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) (product code LTK). 6 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
- Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
- Product code
- LTK
- Country
- United States
Makers of Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Beckman Coulter, Inc. | Chaska, MN, United States | Manufacturer | 2 | May 10, 2024 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 2 | April 6, 2020 | 0 | 1 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 2 | April 6, 2020 | 0 | 2 | 0 | api.fda.gov |
| Fujirebio Diagnostics, Inc. | Seguin, TX, United States | Manufacturer | 1 | May 21, 2015 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | December 12, 2022 | 0 | 1 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer | 1 | April 12, 2011 | 0 | 0 | 0 | api.fda.gov |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fujirebio Diagnostics, Inc. | Malvern, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Monobind, Inc. | Lake Forest, 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.