Data / Medical devices / Ferritin, Antigen, Antiserum, Control / United States
FDA-registered makers of Ferritin, Antigen, Antiserum, Control in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Ferritin, Antigen, Antiserum, Control (product code DBF). 5 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 3, 2026.
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- Device
- Ferritin, Antigen, Antiserum, Control
- Product code
- DBF
- Country
- United States
Makers of Ferritin, Antigen, Antiserum, Control in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 3 | August 31, 2017 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 2 | August 31, 2017 | 0 | 1 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Specification developer | 1 | December 14, 1998 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 1 | September 24, 1999 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | October 22, 1997 | 0 | 0 | 0 | api.fda.gov |
| Alfa Wassermann | West Caldwell, NJ, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CTK Biotech, Inc. | Poway, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immunocentrix Corporation | Canoga Park, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kent Laboratories, Inc. | Bellingham, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov |
Updated November 3, 2026. 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.