Data / Medical devices / Influenza A And Influenza B Multiplex Nucleic Acid Assay / United States
FDA-registered makers of Influenza A And Influenza B Multiplex Nucleic Acid Assay in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Influenza A And Influenza B Multiplex Nucleic Acid Assay (product code OZE). 2 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 3, 2026.
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- Device
- Influenza A And Influenza B Multiplex Nucleic Acid Assay
- Product code
- OZE
- Country
- United States
Makers of Influenza A And Influenza B Multiplex Nucleic Acid Assay in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Centers For Disease Control And Prevention | Atlanta, GA, United States | Complaint file establishment, Manufacturer | 1 | July 11, 2025 | 0 | 1 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Athens, OH, United States | Complaint file establishment, Manufacturer | 1 | August 29, 2013 | 0 | 0 | 0 | api.fda.gov |
| Autonomous Medical Devices Incorporated | Santa Ana, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Diagnostics Scarborough, Inc. | Scarborough, ME, United States | Manufacturer, Specification developer | 0 | 0 | 3 | 0 | api.fda.gov | |
| Abbott Diagnostics Scarborough, Inc. | Portland, ME, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Applied BioCode, Inc. | Santa Fe Springs, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BioFire Diagnostics, LLC | Salt Lake City, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Enercon Technologies | Gray, ME, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Genmark Diagnostics, Inc. | Carlsbad, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Luminex Corporation | Austin, TX, United States | Complaint file establishment, Manufacturer, Remanufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Luminex Corporation | Northbrook, IL, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Molecular Systems, Inc. | Branchburg, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Molecular Systems, Inc. | Pleasanton, CA, United States | Specification developer | 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.