Data / Medical devices / Elisa, Antibody, West Nile Virus
Elisa, Antibody, West Nile Virus (NOP): 7 FDA-registered makers in 2 countries
7 establishments in 2 countries are registered with the FDA to make Elisa, Antibody, West Nile Virus (product code NOP, Class 2, 21 CFR 866.3940). 6 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 August 12, 2016, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NOP
- Device class
- 2
- Regulation
- 866.3940
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Germany | 3 |
Makers of Elisa, Antibody, West Nile Virus
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 |
|---|---|---|---|---|---|---|---|---|
| DiaSorin Molecular LLC | Cypress, CA, United States | Manufacturer | 2 | June 30, 2004 | 0 | 1 | 0 | api.fda.gov |
| Euroimmun Medizinische Labordiagnostika AG | Luebeck Schleswig-Holstein, Germany | Manufacturer | 2 | August 12, 2016 | 0 | 0 | 0 | api.fda.gov |
| EUROIMMUN Medizinische Labordiagnostika AG | Dassow Mecklenburg-Western Pomerania, Germany | Manufacturer | 2 | August 12, 2016 | 0 | 0 | 0 | api.fda.gov |
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Manufacturer | 1 | June 30, 2004 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 1 | November 19, 2004 | 0 | 0 | 0 | api.fda.gov |
| Inbios International, Inc. | Seattle, WA, United States | Manufacturer, Manufacturer for export | 1 | November 19, 2004 | 0 | 0 | 0 | api.fda.gov |
| Roche Molecular Systems, Inc. | Branchburg, NJ, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 12, 2016. 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.