Data / Medical devices / Complement C9, Antigen, Antiserum, Control
Complement C9, Antigen, Antiserum, Control (DAE): 6 FDA-registered makers in 3 countries
6 establishments in 3 countries are registered with the FDA to make Complement C9, Antigen, Antiserum, Control (product code DAE, Class 2, 21 CFR 866.5240). 6 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on August 28, 2015, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- DAE
- Device class
- 2
- Regulation
- 866.5240
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United Kingdom | 2 |
| United States | 2 |
| Japan | 2 |
Makers of Complement C9, 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 |
|---|---|---|---|---|---|---|---|---|
| The Binding Site | Kings Norton Birmingham, United Kingdom | Manufacturer | 2 | August 28, 2015 | 0 | 0 | 0 | api.fda.gov |
| The Binding Site Group Ltd. | Birmingham, United Kingdom | Complaint file establishment, Manufacturer, Repackager or relabeler | 2 | August 28, 2015 | 0 | 0 | 0 | api.fda.gov |
| Diasorin Inc. | Stillwater, MN, United States | Manufacturer | 1 | October 13, 1995 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Healthcare Manufacturing Corporation MIE Office | Komono-cho, Mie-gun, Japan | Manufacturer | 1 | December 18, 1995 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki) | Amagasaki-shi Hyogo, Japan | Specification developer | 1 | December 18, 1995 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Athens, OH, United States | Complaint file establishment, Manufacturer | 1 | July 29, 1998 | 0 | 0 | 0 | api.fda.gov |
Updated August 28, 2015. 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.