Data / Medical devices / Extractable Antinuclear Antibody, Antigen And Control / United States
FDA-registered makers of Extractable Antinuclear Antibody, Antigen And Control in the United States: 11 establishments
11 establishments in the United States are registered with the FDA to make Extractable Antinuclear Antibody, Antigen And Control (product code LLL). 9 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
- Extractable Antinuclear Antibody, Antigen And Control
- Product code
- LLL
- Country
- United States
Makers of Extractable Antinuclear Antibody, Antigen And Control in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Inova Diagnostics, Inc. | San Diego, CA, United States | Manufacturer, Manufacturer for export | 24 | September 29, 2023 | 0 | 0 | 0 | api.fda.gov |
| Hemagen Diagnostics, Inc. | Baltimore, MD, United States | Manufacturer | 17 | June 5, 1995 | 0 | 0 | 0 | api.fda.gov |
| IMMUNO CONCEPTS, NA, Ltd. | Sacramento, CA, United States | Manufacturer | 8 | September 13, 1996 | 0 | 1 | 0 | api.fda.gov |
| Gold Standard Diagnostics, LLC | Davis, CA, United States | Repackager or relabeler, Specification developer | 6 | April 8, 1997 | 0 | 0 | 0 | api.fda.gov |
| Trinity Biotech USA | Jamestown, NY, United States | Manufacturer | 5 | January 12, 2000 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 4 | April 5, 2000 | 0 | 0 | 0 | api.fda.gov |
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer, Repackager or relabeler | 3 | October 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer, Manufacturer for export | 2 | February 22, 1995 | 0 | 0 | 0 | api.fda.gov |
| Immco Diagnostics, Inc. | Williamsville, NY, United States | Manufacturer | 1 | March 31, 2015 | 0 | 0 | 0 | api.fda.gov |
| Calbiotech, Inc. | El Cajon, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Theratest Laboratories, Inc. | Lombard, IL, 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.