Data / Medical devices / Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific (LGC): 14 FDA-registered makers in 4 countries
14 establishments in 4 countries are registered with the FDA to make Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific (product code LGC, Class 2, 21 CFR 866.3305). 9 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 38 510(k) clearances under this code, the latest on November 26, 2003, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LGC
- Device class
- 2
- Regulation
- 866.3305
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| United Kingdom | 2 |
| Ireland | 1 |
| Spain | 1 |
Makers of Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| 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-Diagnostics Ltd. | Worcestershire, United Kingdom | Manufacturer | 1 | August 19, 1999 | 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 Products Limited | LLANBERIS Wales, United Kingdom | Manufacturer | 1 | April 18, 2001 | 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 |
| Abbott Ireland | Sligo, Ireland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biokit S.A. | LLISSA D AMUNT Barcelona, Spain | Manufacturer | 0 | 0 | 1 | 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 26, 2003. 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.