Data / Medical devices / Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 (MYF): 12 FDA-registered makers in 4 countries
12 establishments in 4 countries are registered with the FDA to make Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 (product code MYF, Class 2, 21 CFR 866.3305). 9 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on February 12, 2025, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MYF
- Device class
- 2
- Regulation
- 866.3305
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Spain | 1 |
| Ireland | 1 |
| Germany | 1 |
Makers of Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
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 |
|---|---|---|---|---|---|---|---|---|
| Biokit S.A. | LLISSA D AMUNT Barcelona, Spain | Manufacturer | 2 | February 12, 2025 | 0 | 0 | 0 | api.fda.gov |
| Abbott Ireland | Sligo, Ireland | Specification developer | 1 | February 12, 2025 | 0 | 0 | 0 | api.fda.gov |
| Arlington Scientific, Inc. | Springville, UT, United States | Manufacturer | 1 | May 13, 2016 | 0 | 0 | 0 | api.fda.gov |
| Diasorin Inc. | Stillwater, MN, United States | Manufacturer | 1 | November 10, 2008 | 0 | 1 | 0 | api.fda.gov |
| DiaSorin Molecular LLC | Cypress, CA, United States | Manufacturer | 1 | February 1, 2000 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Manufacturer, Repackager or relabeler | 1 | October 12, 2022 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | August 23, 2018 | 0 | 0 | 0 | api.fda.gov |
| Trinity Biotech USA | Jamestown, NY, United States | Manufacturer, Manufacturer for export | 1 | July 13, 2004 | 0 | 0 | 0 | api.fda.gov |
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer | 1 | May 20, 2011 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Woodinville, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 12, 2025. 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.