Data / Medical devices / Radioimmunoassay, Parathyroid Hormone / United States
FDA-registered makers of Radioimmunoassay, Parathyroid Hormone in the United States: 11 establishments
11 establishments in the United States are registered with the FDA to make Radioimmunoassay, Parathyroid Hormone (product code CEW). 6 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 2, 2026.
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- Device
- Radioimmunoassay, Parathyroid Hormone
- Product code
- CEW
- Country
- United States
Makers of Radioimmunoassay, Parathyroid Hormone 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 | 4 | May 23, 2017 | 0 | 1 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 3 | May 23, 2017 | 0 | 4 | 0 | api.fda.gov |
| Diasorin Inc. | Stillwater, MN, United States | Manufacturer | 2 | June 22, 2015 | 0 | 1 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 2 | September 5, 2023 | 0 | 1 | 0 | api.fda.gov |
| Biomerica | Irvine, CA, United States | Manufacturer | 1 | December 23, 1997 | 0 | 0 | 0 | api.fda.gov |
| Scientific Supplies & Technology, Inc. | Doral, FL, United States | Remanufacturer, Repackager or relabeler | 1 | August 21, 2002 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Chaska, MN, United States | Contract manufacturer | 0 | 0 | 1 | 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 | |
| Monobind, Inc. | Lake Forest, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer, Specification developer | 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.