Data / Medical devices / Epstein-Barr Virus, Other / United States
FDA-registered makers of Epstein-Barr Virus, Other in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Epstein-Barr Virus, Other (product code LSE). 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
- Epstein-Barr Virus, Other
- Product code
- LSE
- Country
- United States
Makers of Epstein-Barr Virus, Other in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Gold Standard Diagnostics, LLC | Davis, CA, United States | Repackager or relabeler, Specification developer | 4 | March 4, 1999 | 0 | 0 | 0 | api.fda.gov |
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer, Repackager or relabeler | 4 | December 22, 1999 | 0 | 0 | 0 | api.fda.gov |
| Trinity Biotech USA | Jamestown, NY, United States | Manufacturer | 3 | July 22, 1998 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Woodinville, WA, United States | Contract manufacturer, Manufacturer for export, Specification developer | 2 | January 16, 2004 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Complaint file establishment, Specification developer | 2 | December 8, 2006 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 2 | September 25, 1995 | 0 | 0 | 0 | api.fda.gov |
| IMMUNO CONCEPTS, NA, Ltd. | Sacramento, CA, United States | Manufacturer | 2 | July 24, 1991 | 0 | 0 | 0 | api.fda.gov |
| Biocare Medical, LLC | Pacheco, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Calbiotech, Inc. | El Cajon, CA, United States | Contract manufacturer | 0 | 0 | 1 | 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.