Data / Medical devices / Ige, Antigen, Antiserum, Control
Ige, Antigen, Antiserum, Control (DGC): 18 FDA-registered makers in 7 countries
18 establishments in 7 countries are registered with the FDA to make Ige, Antigen, Antiserum, Control (product code DGC, Class 2, 21 CFR 866.5510). 14 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 114 510(k) clearances under this code, the latest on May 31, 2024, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DGC
- Device class
- 2
- Regulation
- 866.5510
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| United Kingdom | 3 |
| Germany | 2 |
| Ireland | 2 |
| Japan | 2 |
| Spain | 1 |
| Sweden | 1 |
Makers of Ige, 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 |
|---|---|---|---|---|---|---|---|---|
| Biokit S.A. | LLISSA D AMUNT Barcelona, Spain | Exporter to the US, Repackager or relabeler, Specification developer | 2 | February 21, 2023 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 2 | January 15, 2020 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Products GmbH | MARBURG Hesse, Germany | Manufacturer | 2 | February 15, 2007 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Specification developer | 1 | February 24, 2003 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter Ireland Inc | O CALLAGHANS MILLS Clare, Ireland | Manufacturer, Specification developer | 1 | March 23, 2022 | 0 | 0 | 0 | api.fda.gov |
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Manufacturer | 1 | September 21, 1999 | 0 | 0 | 0 | api.fda.gov |
| Phadia AB | Uppsala, Sweden | Complaint file establishment, Manufacturer | 1 | February 24, 2014 | 0 | 0 | 0 | api.fda.gov |
| Randox Laboratories Limited | CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom | Manufacturer | 1 | May 15, 2001 | 0 | 0 | 0 | api.fda.gov |
| Shima Laboratories Co., Ltd. | ITABASHI-KU Tokyo, Japan | Contract manufacturer, Manufacturer | 1 | December 10, 2004 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc | East Walpole, MA, United States | Manufacturer | 1 | January 15, 2020 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 1 | April 8, 1992 | 0 | 0 | 0 | api.fda.gov |
| The Binding Site | Kings Norton Birmingham, United Kingdom | Manufacturer | 1 | October 26, 2000 | 0 | 0 | 0 | api.fda.gov |
| Tosoh Aia, Inc. | Toyama, Japan | Manufacturer | 1 | October 3, 1997 | 0 | 0 | 0 | api.fda.gov |
| The Binding Site Group Ltd. | Birmingham, United Kingdom | Complaint file establishment, Manufacturer | 1 | October 26, 2000 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Canon Medical Diagnostics USA, Inc. | Mountain View, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immunocentrix Corporation | Canoga Park, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Manufacturing Ltd. | SWORDS Dublin(County), Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 31, 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.