Data / Medical devices / Radioimmunoassay, Testosterones And Dihydrotestosterone
Radioimmunoassay, Testosterones And Dihydrotestosterone (CDZ): 34 FDA-registered makers in 12 countries
34 establishments in 12 countries are registered with the FDA to make Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ, Class 1, 21 CFR 862.1680). 20 of them have a 510(k) clearance or PMA approval on file and 7 have a recall event. The FDA has issued 89 510(k) clearances under this code, the latest on April 15, 2026, and lists 18 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- CDZ
- Device class
- 1
- Regulation
- 862.1680
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 17 |
| United Kingdom | 4 |
| Germany | 3 |
| South Korea | 2 |
| Canada | 1 |
| Japan | 1 |
| Spain | 1 |
| Czechia | 1 |
| Italy | 1 |
| Hungary | 1 |
| France | 1 |
| Ireland | 1 |
Makers of Radioimmunoassay, Testosterones And Dihydrotestosterone
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| 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 |
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Manufacturer | 4 | July 20, 2018 | 0 | 1 | 0 | api.fda.gov |
| Immunodiagnostic Systems Ltd. | Boldon Colliery Durham, United Kingdom | Manufacturer | 3 | April 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Manufacturer | 3 | May 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Products Limited | LLANBERIS Wales, United Kingdom | Manufacturer | 3 | October 10, 2003 | 0 | 0 | 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 |
| Diagnostics Biochem Canada, Inc. | London Ontario, Canada | Manufacturer | 2 | August 18, 2003 | 0 | 0 | 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 |
| Tosoh Aia, Inc. | Toyama, Japan | Manufacturer | 2 | July 2, 2015 | 0 | 0 | 0 | api.fda.gov |
| Biokit S.A. | LLISSA D AMUNT Barcelona, Spain | Manufacturer | 1 | January 23, 2007 | 0 | 0 | 0 | api.fda.gov |
| Diasorin Inc. | Stillwater, MN, United States | Manufacturer, Manufacturer for export | 1 | January 25, 2013 | 0 | 0 | 0 | api.fda.gov |
| IMMUNOTECH s.r.o. | Prague Praha, Hlavni Mesto, Czechia | Manufacturer | 1 | December 20, 2019 | 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 |
| Nanoentek Inc | Hwaseong Gyeonggi, South Korea | Manufacturer | 1 | October 14, 2016 | 0 | 0 | 0 | api.fda.gov |
| Nanoentek Inc | Seoul, South Korea | Specification developer | 1 | October 14, 2016 | 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 |
| Axis-Shield Diagnostics, Ltd. | DUNDEE Scotland, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bio-Analysis, Inc. | Santa Monica, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerieux Italia-Industrial Div. | PONTE-A EMA, FLORENCE Firenze, Italy | 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 | |
| Diamond Diagnostics Inc. | Budapest, Hungary | Contract manufacturer, Exporter to the US | 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 | |
| Ibl International GMBH | Hamburg, Germany | 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 | |
| Immunotech SAS, a Beckman Coulter company | MARSEILLE, CEDEX 9 Bouches-du-Rhone, France | Contract manufacturer | 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 | |
| Ortho-Clinical Diagnostics | Pencoed Bridgend, United Kingdom | Manufacturer | 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 Manufacturing Ltd. | SWORDS Dublin(County), Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 15, 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.