Data / Medical devices / Radioimmunoassay, Testosterones And Dihydrotestosterone / United States
FDA-registered makers of Radioimmunoassay, Testosterones And Dihydrotestosterone in the United States: 17 establishments
17 establishments in the United States are registered with the FDA to make Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ). 10 have a 510(k) clearance or PMA approval on file and 6 have a recall event. FDA data exported November 3, 2026.
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- Device
- Radioimmunoassay, Testosterones And Dihydrotestosterone
- Product code
- CDZ
- Country
- United States
Makers of Radioimmunoassay, Testosterones And Dihydrotestosterone 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 | 4 | February 8, 2024 | 0 | 1 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 3 | August 28, 2019 | 0 | 1 | 0 | api.fda.gov |
| Abbott Laboratories | Abbott Park, IL, United States | Specification developer | 2 | December 17, 2015 | 0 | 1 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 2 | July 20, 2018 | 0 | 0 | 0 | api.fda.gov |
| Qualigen, Inc. | Carlsbad, CA, United States | Complaint file establishment, Manufacturer | 2 | January 29, 2019 | 0 | 4 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 2 | August 28, 2019 | 0 | 1 | 0 | api.fda.gov |
| Diasorin Inc. | Stillwater, MN, United States | Manufacturer, Manufacturer for export | 1 | January 25, 2013 | 0 | 0 | 0 | api.fda.gov |
| Monobind, Inc. | Lake Forest, CA, United States | Manufacturer | 1 | July 20, 2018 | 0 | 0 | 0 | api.fda.gov |
| MP Biomedicals Diagnostics Division | Solon, OH, United States | Manufacturer | 1 | October 30, 1979 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer | 1 | February 11, 2016 | 0 | 1 | 0 | api.fda.gov |
| Bio-Analysis, Inc. | Santa Monica, CA, United States | 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 | |
| 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 | |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 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.