Data / Medical devices / Ceruloplasmin, Antigen, Antiserum, Control
Ceruloplasmin, Antigen, Antiserum, Control (DDB): 7 FDA-registered makers in 4 countries
7 establishments in 4 countries are registered with the FDA to make Ceruloplasmin, Antigen, Antiserum, Control (product code DDB, Class 2, 21 CFR 866.5210). 6 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 19 510(k) clearances under this code, the latest on January 9, 2017, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DDB
- Device class
- 2
- Regulation
- 866.5210
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| United Kingdom | 2 |
| Ireland | 1 |
| Germany | 1 |
Makers of Ceruloplasmin, 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 |
|---|---|---|---|---|---|---|---|---|
| Kent Laboratories, Inc. | Bellingham, WA, United States | Manufacturer | 2 | November 25, 1985 | 0 | 0 | 0 | api.fda.gov |
| The Binding Site | Kings Norton Birmingham, United Kingdom | Manufacturer | 2 | June 3, 2013 | 0 | 0 | 0 | api.fda.gov |
| The Binding Site Group Ltd. | Birmingham, United Kingdom | Complaint file establishment, Manufacturer | 2 | June 3, 2013 | 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 |
| Beckman Coulter Ireland Inc | O CALLAGHANS MILLS Clare, Ireland | Manufacturer | 1 | January 9, 2017 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Products GmbH | MARBURG Hesse, Germany | Manufacturer | 1 | March 16, 2006 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 9, 2017. 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.