Data / Medical devices / Complement C1q, Antigen, Antiserum, Control
Complement C1q, Antigen, Antiserum, Control (DAK): 8 FDA-registered makers in 3 countries
8 establishments in 3 countries are registered with the FDA to make Complement C1q, Antigen, Antiserum, Control (product code DAK, Class 2, 21 CFR 866.5240). 8 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 28 510(k) clearances under this code, the latest on September 10, 2003, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DAK
- Device class
- 2
- Regulation
- 866.5240
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| United Kingdom | 2 |
| Switzerland | 1 |
Makers of Complement C1q, 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 |
|---|---|---|---|---|---|---|---|---|
| Ortho-Clinical Diagnostics, Inc. | Athens, OH, United States | Complaint file establishment, Manufacturer | 2 | August 4, 1988 | 0 | 2 | 0 | api.fda.gov |
| Buhlmann Laboratories AG | SCHONENBUCH/BASEL Basel-Landschaft, Switzerland | Manufacturer | 1 | January 29, 2002 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories Inc. | Irvine, CA, United States | Manufacturer | 1 | April 29, 1985 | 0 | 0 | 0 | api.fda.gov |
| Inova Diagnostics, Inc. | San Diego, CA, United States | Manufacturer, Manufacturer for export | 1 | September 10, 2003 | 0 | 1 | 0 | api.fda.gov |
| Kent Laboratories, Inc. | Bellingham, WA, United States | Manufacturer | 1 | May 30, 1995 | 0 | 0 | 0 | api.fda.gov |
| The Binding Site | Kings Norton Birmingham, United Kingdom | Manufacturer | 1 | October 28, 1991 | 0 | 0 | 0 | api.fda.gov |
| The Binding Site Group Ltd. | Birmingham, United Kingdom | Complaint file establishment, Manufacturer | 1 | October 28, 1991 | 0 | 0 | 0 | api.fda.gov |
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer | 1 | March 17, 1998 | 0 | 0 | 0 | api.fda.gov |
Updated September 10, 2003. 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.