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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

CountryMakers
United States17
United Kingdom4
Germany3
South Korea2
Canada1
Japan1
Spain1
Czechia1
Italy1
Hungary1
France1
Ireland1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Beckman Coulter, Inc.Chaska, MN, United StatesManufacturer4February 8, 2024010api.fda.gov
DRG Instruments GMBHMARBURG Hesse, GermanyComplaint file establishment, Manufacturer4July 20, 2018010api.fda.gov
Immunodiagnostic Systems Ltd.Boldon Colliery Durham, United KingdomManufacturer3April 15, 2026000api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyManufacturer3May 6, 2022000api.fda.gov
Siemens Healthcare Diagnostics Products LimitedLLANBERIS Wales, United KingdomManufacturer3October 10, 2003000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer3August 28, 2019010api.fda.gov
Abbott LaboratoriesAbbott Park, IL, United StatesSpecification developer2December 17, 2015010api.fda.gov
Diagnostics Biochem Canada, Inc.London Ontario, CanadaManufacturer2August 18, 2003000api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer2July 20, 2018000api.fda.gov
Qualigen, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer2January 29, 2019040api.fda.gov
Siemens Healthcare Diagnostics Inc.E Walpole, MA, United StatesManufacturer2August 28, 2019010api.fda.gov
Tosoh Aia, Inc.Toyama, JapanManufacturer2July 2, 2015000api.fda.gov
Biokit S.A.LLISSA D AMUNT Barcelona, SpainManufacturer1January 23, 2007000api.fda.gov
Diasorin Inc.Stillwater, MN, United StatesManufacturer, Manufacturer for export1January 25, 2013000api.fda.gov
IMMUNOTECH s.r.o.Prague Praha, Hlavni Mesto, CzechiaManufacturer1December 20, 2019000api.fda.gov
Monobind, Inc.Lake Forest, CA, United StatesManufacturer1July 20, 2018000api.fda.gov
MP Biomedicals Diagnostics DivisionSolon, OH, United StatesManufacturer1October 30, 1979000api.fda.gov
Nanoentek IncHwaseong Gyeonggi, South KoreaManufacturer1October 14, 2016000api.fda.gov
Nanoentek IncSeoul, South KoreaSpecification developer1October 14, 2016000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer1February 11, 2016010api.fda.gov
Axis-Shield Diagnostics, Ltd.DUNDEE Scotland, United KingdomContract manufacturer0000api.fda.gov
Bio-Analysis, Inc.Santa Monica, CA, United StatesManufacturer0000api.fda.gov
Biomerieux Italia-Industrial Div.PONTE-A EMA, FLORENCE Firenze, ItalyManufacturer0000api.fda.gov
CTK Biotech, Inc.Poway, CA, United StatesManufacturer for export0000api.fda.gov
DIAMOND DIAGNOSTICS IncHolliston, MA, United StatesContract manufacturer0000api.fda.gov
Diamond Diagnostics Inc.Budapest, HungaryContract manufacturer, Exporter to the US0000api.fda.gov
Epitope Diagnostics, Inc.San Diego, CA, United StatesManufacturer for export0000api.fda.gov
Ibl International GMBHHamburg, GermanyManufacturer0000api.fda.gov
Immunocentrix CorporationCanoga Park, CA, United StatesManufacturer for export0000api.fda.gov
Immunotech SAS, a Beckman Coulter companyMARSEILLE, CEDEX 9 Bouches-du-Rhone, FranceContract manufacturer0000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Ortho-Clinical DiagnosticsPencoed Bridgend, United KingdomManufacturer0000api.fda.gov
Scientific Supplies & Technology, Inc.Doral, FL, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
Siemens Healthcare Diagnostics Manufacturing Ltd.SWORDS Dublin(County), IrelandManufacturer0000api.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.