Data / Medical devices / Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 (MXJ): 13 FDA-registered makers in 3 countries
13 establishments in 3 countries are registered with the FDA to make Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 (product code MXJ, Class 2, 21 CFR 866.3305). 10 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 20 510(k) clearances under this code, the latest on September 20, 2023, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MXJ
- Device class
- 2
- Regulation
- 866.3305
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| Germany | 2 |
| Spain | 1 |
Makers of Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
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 | September 20, 2023 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Complaint file establishment, Specification developer | 2 | June 22, 2012 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Manufacturer, Repackager or relabeler | 2 | October 12, 2022 | 0 | 0 | 0 | api.fda.gov |
| Zeus Scientific LLC | Branchburg, NJ, United States | Manufacturer | 2 | April 26, 2011 | 0 | 0 | 0 | api.fda.gov |
| Arlington Scientific, Inc. | Springville, UT, United States | Manufacturer | 1 | October 1, 2016 | 0 | 0 | 0 | api.fda.gov |
| Diasorin Inc. | Stillwater, MN, United States | Manufacturer | 1 | November 18, 2008 | 0 | 0 | 0 | api.fda.gov |
| DiaSorin Molecular LLC | Cypress, CA, United States | Manufacturer | 1 | February 9, 2000 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 1 | May 30, 2008 | 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 |
| Bio-Rad Laboratories, Inc. | Woodinville, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Monobind, Inc. | Lake Forest, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 20, 2023. 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.