Data / Medical devices / Alpha-1-Antitrypsin, Antigen, Antiserum, Control
Alpha-1-Antitrypsin, Antigen, Antiserum, Control (DEM): 18 FDA-registered makers in 7 countries
18 establishments in 7 countries are registered with the FDA to make Alpha-1-Antitrypsin, Antigen, Antiserum, Control (product code DEM, Class 2, 21 CFR 866.5130). 12 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 30 510(k) clearances under this code, the latest on July 3, 2013, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DEM
- Device class
- 2
- Regulation
- 866.5130
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Germany | 3 |
| United Kingdom | 3 |
| Spain | 1 |
| Ireland | 1 |
| Japan | 1 |
| Switzerland | 1 |
Makers of Alpha-1-Antitrypsin, 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 |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Products GmbH | MARBURG Hesse, Germany | Manufacturer | 2 | January 11, 2007 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Specification developer | 1 | April 25, 1997 | 0 | 0 | 0 | api.fda.gov |
| Biokit S.A. | LLISSA D AMUNT Barcelona, Spain | Exporter to the US, Repackager or relabeler, Specification developer | 1 | May 13, 2005 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter Ireland Inc | O CALLAGHANS MILLS Clare, Ireland | Manufacturer | 1 | November 24, 1999 | 0 | 0 | 0 | api.fda.gov |
| Kamiya Biomedical Company LLC | Tukwila, WA, United States | Manufacturer | 1 | November 24, 1999 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer, Repackager or relabeler | 1 | December 23, 2005 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | December 23, 2005 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer | 1 | May 18, 2001 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer | 1 | January 11, 2007 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | January 11, 2007 | 0 | 0 | 0 | api.fda.gov |
| The Binding Site | Kings Norton Birmingham, United Kingdom | Manufacturer | 1 | July 3, 2013 | 0 | 0 | 0 | api.fda.gov |
| The Binding Site Group Ltd. | Birmingham, United Kingdom | Complaint file establishment, Manufacturer | 1 | July 3, 2013 | 0 | 1 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kent Laboratories, Inc. | Bellingham, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nittobo Medical Co., Ltd. Medical Development Center | Koriyama Fukushima, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Randox Laboratories Limited | CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom | Contract manufacturer | 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 |
Updated July 3, 2013. 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.