Data / Medical devices / Lipoprotein, Low-Density, Antigen, Antiserum, Control / United States
FDA-registered makers of Lipoprotein, Low-Density, Antigen, Antiserum, Control in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Lipoprotein, Low-Density, Antigen, Antiserum, Control (product code DFC). 7 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Lipoprotein, Low-Density, Antigen, Antiserum, Control
- Product code
- DFC
- Country
- United States
Makers of Lipoprotein, Low-Density, Antigen, Antiserum, Control in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Diazyme Laboratories, Inc. | Poway, CA, United States | Manufacturer | 2 | June 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| Kamiya Biomedical Company LLC | Tukwila, WA, United States | Manufacturer | 2 | December 13, 2002 | 0 | 1 | 0 | api.fda.gov |
| Abbott Laboratories | Irving, TX, United States | Specification developer | 1 | January 26, 1999 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Specification developer | 1 | May 17, 2000 | 0 | 0 | 0 | api.fda.gov |
| Cliniqa Corporation | San Marcos, CA, United States | Manufacturer | 1 | June 15, 1987 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 1 | November 26, 1999 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | December 20, 2012 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher Diagnostics | Middletown, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trinity Biotech USA | Jamestown, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.