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Data / Medical devices / Transferrin, Antigen, Antiserum, Control

Transferrin, Antigen, Antiserum, Control (DDG): 22 FDA-registered makers in 6 countries

22 establishments in 6 countries are registered with the FDA to make Transferrin, Antigen, Antiserum, Control (product code DDG, Class 2, 21 CFR 866.5880). 14 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 48 510(k) clearances under this code, the latest on July 3, 2024, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
DDG
Device class
2
Regulation
866.5880
Medical specialty
Immunology

Makers by country

CountryMakers
United States13
Germany3
United Kingdom3
Japan1
France1
Switzerland1

Makers of Transferrin, Antigen, Antiserum, Control

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
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyExporter to the US, Manufacturer, Repackager or relabeler, Specification developer4November 5, 2018000api.fda.gov
Siemens Healthcare Diagnostics Products GmbHMARBURG Hesse, GermanyManufacturer4August 8, 2008000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesSpecification developer3August 20, 1997000api.fda.gov
Beckman Coulter, Inc.Chaska, MN, United StatesManufacturer2July 3, 2024000api.fda.gov
Abbott LaboratoriesIrving, TX, United StatesSpecification developer1November 4, 1998000api.fda.gov
Kamiya Biomedical Company LLCTukwila, WA, United StatesManufacturer1November 30, 1999000api.fda.gov
Kent Laboratories, Inc.Bellingham, WA, United StatesManufacturer1August 12, 1981000api.fda.gov
Nittobo Medical Co., Ltd. Medical Development CenterKoriyama Fukushima, JapanContract manufacturer, Manufacturer1November 4, 1998000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer, Repackager or relabeler1November 19, 2004000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer1November 19, 2004000api.fda.gov
Randox Laboratories LimitedCRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomContract manufacturer, Manufacturer1February 5, 2001000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer, Specification developer1February 4, 2000000api.fda.gov
The Binding SiteKings Norton Birmingham, United KingdomManufacturer1February 13, 2013000api.fda.gov
The Binding Site Group Ltd.Birmingham, United KingdomComplaint file establishment, Manufacturer1February 13, 2013000api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Diasorin Inc.Stillwater, MN, United StatesContract manufacturer0000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer0000api.fda.gov
Horiba Abx SASMONTPELLIER Herault, FranceSpecification developer0000api.fda.gov
Monobind, Inc.Lake Forest, CA, United StatesManufacturer for export0000api.fda.gov
Roche Diagnostics GMBHPENZBERG Bavaria, GermanyManufacturer0000api.fda.gov
Roche Diagnostics International Ltd.ROTKREUZ Zug, SwitzerlandManufacturer0000api.fda.gov
Victorch Meditek, Inc.San Diego, CA, United StatesManufacturer for export0000api.fda.gov

Updated July 3, 2024. 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.