Data / Medical devices / Influenza A And Influenza B Multiplex Nucleic Acid Assay
Influenza A And Influenza B Multiplex Nucleic Acid Assay (OZE): 16 FDA-registered makers in 4 countries
16 establishments in 4 countries are registered with the FDA to make Influenza A And Influenza B Multiplex Nucleic Acid Assay (product code OZE, Class 2, 21 CFR 866.3980). 2 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 21 510(k) clearances under this code, the latest on September 30, 2026, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OZE
- Device class
- 2
- Regulation
- 866.3980
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 13 |
| Malaysia | 1 |
| China | 1 |
| Switzerland | 1 |
Makers of Influenza A And Influenza B Multiplex Nucleic Acid Assay
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 |
|---|---|---|---|---|---|---|---|---|
| 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 | |
| Hochuen Medical Sdn. Bhd. | SENAI Johor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hochuen Medical Technology Co.,Ltd. | Shenzhen Guangdong, China | Contract 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 Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | 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 September 30, 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.