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
| Country | Makers |
|---|---|
| United States | 13 |
| Germany | 3 |
| United Kingdom | 3 |
| Japan | 1 |
| France | 1 |
| Switzerland | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer | 4 | November 5, 2018 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Products GmbH | MARBURG Hesse, Germany | Manufacturer | 4 | August 8, 2008 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Specification developer | 3 | August 20, 1997 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Chaska, MN, United States | Manufacturer | 2 | July 3, 2024 | 0 | 0 | 0 | api.fda.gov |
| Abbott Laboratories | Irving, TX, United States | Specification developer | 1 | November 4, 1998 | 0 | 0 | 0 | api.fda.gov |
| Kamiya Biomedical Company LLC | Tukwila, WA, United States | Manufacturer | 1 | November 30, 1999 | 0 | 0 | 0 | api.fda.gov |
| Kent Laboratories, Inc. | Bellingham, WA, United States | Manufacturer | 1 | August 12, 1981 | 0 | 0 | 0 | api.fda.gov |
| Nittobo Medical Co., Ltd. Medical Development Center | Koriyama Fukushima, Japan | Contract manufacturer, Manufacturer | 1 | November 4, 1998 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer, Repackager or relabeler | 1 | November 19, 2004 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | November 19, 2004 | 0 | 0 | 0 | api.fda.gov |
| Randox Laboratories Limited | CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom | Contract manufacturer, Manufacturer | 1 | February 5, 2001 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer, Specification developer | 1 | February 4, 2000 | 0 | 0 | 0 | api.fda.gov |
| The Binding Site | Kings Norton Birmingham, United Kingdom | Manufacturer | 1 | February 13, 2013 | 0 | 0 | 0 | api.fda.gov |
| The Binding Site Group Ltd. | Birmingham, United Kingdom | Complaint file establishment, Manufacturer | 1 | February 13, 2013 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diasorin Inc. | Stillwater, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher Diagnostics | Middletown, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Horiba Abx SAS | MONTPELLIER Herault, France | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Monobind, Inc. | Lake Forest, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics GMBH | PENZBERG Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Victorch Meditek, Inc. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.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.