Data / Medical devices / Test, Antigen, Nuclear, Epstein-Barr Virus / United States
FDA-registered makers of Test, Antigen, Nuclear, Epstein-Barr Virus in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Test, Antigen, Nuclear, Epstein-Barr Virus (product code LLM). 6 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Test, Antigen, Nuclear, Epstein-Barr Virus
- Product code
- LLM
- Country
- United States
Makers of Test, Antigen, Nuclear, Epstein-Barr Virus in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 3 | May 1, 1998 | 0 | 0 | 0 | api.fda.gov |
| IMMUNO CONCEPTS, NA, Ltd. | Sacramento, CA, United States | Manufacturer | 2 | December 11, 1989 | 0 | 0 | 0 | api.fda.gov |
| Trinity Biotech USA | Jamestown, NY, United States | Manufacturer | 2 | May 1, 1998 | 0 | 0 | 0 | api.fda.gov |
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer | 2 | May 5, 1995 | 0 | 0 | 0 | api.fda.gov |
| Bion Enterprises, Ltd. | Des Plaines, IL, United States | Contract manufacturer, Manufacturer | 1 | October 16, 1989 | 0 | 0 | 0 | api.fda.gov |
| VMRD, Inc. | Fullerton, CA, United States | Manufacturer | 1 | October 12, 1993 | 0 | 0 | 0 | api.fda.gov |
| Immunocentrix Corporation | Canoga Park, CA, United States | Manufacturer for export | 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.