Data / Medical devices / Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific / United States
FDA-registered makers of Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific (product code LGC). 7 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
- Product code
- LGC
- Country
- United States
Makers of Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific 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 | 2 | November 28, 2000 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Woodinville, WA, United States | Specification developer | 1 | January 22, 1997 | 0 | 0 | 0 | api.fda.gov |
| DiaSorin Molecular LLC | Cypress, CA, United States | Manufacturer | 1 | April 14, 2000 | 0 | 1 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 1 | March 18, 1999 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | April 18, 2001 | 0 | 0 | 0 | api.fda.gov |
| Trinity Biotech USA | Jamestown, NY, United States | Manufacturer, Manufacturer for export | 1 | November 26, 2003 | 0 | 0 | 0 | api.fda.gov |
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer | 1 | March 18, 1999 | 0 | 0 | 0 | api.fda.gov |
| Calbiotech, Inc. | El Cajon, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immunocentrix Corporation | Canoga Park, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Supplies & Technology, Inc. | Doral, FL, United States | Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 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.