Data / Medical devices / Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control (DBA): 5 FDA-registered makers in 3 countries
5 establishments in 3 countries are registered with the FDA to make Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control (product code DBA, Class 2, 21 CFR 866.5250). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on July 18, 2014, and lists 1 recall event (0 Class I). FDA data exported November 3, 2026.
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- Product code
- DBA
- Device class
- 2
- Regulation
- 866.5250
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| United Kingdom | 2 |
| Germany | 1 |
Makers of Complement C1 Inhibitor (Inactivator), 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 | December 21, 2007 | 0 | 0 | 0 | api.fda.gov |
| Kent Laboratories, Inc. | Bellingham, WA, United States | Manufacturer | 1 | May 30, 1995 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Athens, OH, United States | Complaint file establishment, Manufacturer | 1 | July 23, 1987 | 0 | 1 | 0 | api.fda.gov |
| The Binding Site | Kings Norton Birmingham, United Kingdom | Manufacturer | 1 | July 18, 2014 | 0 | 0 | 0 | api.fda.gov |
| The Binding Site Group Ltd. | Birmingham, United Kingdom | Complaint file establishment, Manufacturer | 1 | July 18, 2014 | 0 | 0 | 0 | api.fda.gov |
Updated July 18, 2014. 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.