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Data / Medical devices / Radioimmunoassay, Total Triiodothyronine

Radioimmunoassay, Total Triiodothyronine (CDP): 34 FDA-registered makers in 12 countries

34 establishments in 12 countries are registered with the FDA to make Radioimmunoassay, Total Triiodothyronine (product code CDP, Class 2, 21 CFR 862.1710). 11 of them have a 510(k) clearance or PMA approval on file and 6 have a recall event. The FDA has issued 144 510(k) clearances under this code, the latest on October 5, 2000, and lists 16 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
CDP
Device class
2
Regulation
862.1710
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
United States12
China5
Ireland3
Germany3
South Korea3
United Kingdom2
Japan1
Canada1
Italy1
Belgium1
France1
India1

Makers of Radioimmunoassay, Total Triiodothyronine

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
Abbott Ireland Diagnostics DivisionLongford, IrelandManufacturer2November 20, 1998020api.fda.gov
DRG Instruments GMBHMARBURG Hesse, GermanyComplaint file establishment, Manufacturer2June 2, 1999000api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer2June 2, 1999000api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler2December 16, 1996000api.fda.gov
Tosoh Aia, Inc.Toyama, JapanManufacturer2May 11, 1999000api.fda.gov
Beckman Coulter, Inc.Chaska, MN, United StatesContract manufacturer, Manufacturer1October 31, 1997010api.fda.gov
Monobind, Inc.Lake Forest, CA, United StatesManufacturer1June 16, 1997000api.fda.gov
Siemens Healthcare Diagnostics Products LimitedLLANBERIS Wales, United KingdomManufacturer1January 2, 1998000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer1June 18, 1999010api.fda.gov
Siemens Healthcare Diagnostics Inc.E Walpole, MA, United StatesManufacturer, Repackager or relabeler, Specification developer1June 18, 1999010api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer for export, Repackager or relabeler1June 2, 1999000api.fda.gov
Beijing Hotgen Biotech Co., Ltd.Beijing, ChinaManufacturer0000api.fda.gov
Boditech Med Inc.Chuncheon Gangwon, South KoreaManufacturer0000api.fda.gov
Beckman Coulter Ireland IncO CALLAGHANS MILLS Clare, IrelandContract manufacturer0000api.fda.gov
CTK Biotech, Inc.Poway, CA, United StatesManufacturer0000api.fda.gov
Diagnostics Biochem Canada, Inc.London Ontario, CanadaManufacturer0000api.fda.gov
Dirui Industrial Co., Ltd.CHANGCHUN Jilin, ChinaManufacturer0000api.fda.gov
DiaSorin Deutschland GmbHDietzenbach Hesse, GermanyContract manufacturer0000api.fda.gov
DiaSorin Italia S.p.A.SALUGGIA Vercelli, ItalyManufacturer0000api.fda.gov
DiaSource ImmunoAssays, SALouvain-La-Neuve Brabant Wallon, BelgiumManufacturer0000api.fda.gov
Epitope Diagnostics, Inc.San Diego, CA, United StatesManufacturer0000api.fda.gov
Getein Biotech, Inc.Nanjing Jiangsu, ChinaManufacturer0000api.fda.gov
Immunocentrix CorporationCanoga Park, CA, United StatesManufacturer for export0000api.fda.gov
Immunotech SAS, a Beckman Coulter companyMARSEILLE, CEDEX 9 Bouches-du-Rhone, FranceSpecification developer0000api.fda.gov
Lords Mark Industries Ltd.Daman and Diu Dadra and Nagar Haveli, IndiaManufacturer0000api.fda.gov
Nanoentek IncHwaseong Gyeonggi, South KoreaManufacturer0000api.fda.gov
Nanoentek IncSeoul, South KoreaSpecification developer0000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer0010api.fda.gov
Ortho-Clinical DiagnosticsPencoed Bridgend, United KingdomManufacturer0010api.fda.gov
Scientific Supplies & Technology, Inc.Doral, FL, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
Shenzhen Yhlo Biotech Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shijiazhuang Hipro Biotechnology Co.,ltdShijiazhuang Hebei, ChinaManufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Manufacturing Ltd.SWORDS Dublin(County), IrelandManufacturer0000api.fda.gov

Updated October 5, 2000. 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.