Data / Medical devices / Devices Detecting Influenza A, B, And C Virus Antigens / United States
FDA-registered makers of Devices Detecting Influenza A, B, And C Virus Antigens in the United States: 22 establishments
22 establishments in the United States are registered with the FDA to make Devices Detecting Influenza A, B, And C Virus Antigens (product code PSZ). 17 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 3, 2026.
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- Device
- Devices Detecting Influenza A, B, And C Virus Antigens
- Product code
- PSZ
- Country
- United States
Makers of Devices Detecting Influenza A, B, And C Virus Antigens in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Becton, Dickinson & Co. | San Diego, CA, United States | Specification developer | 17 | December 5, 2023 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Manufacturer | 17 | December 5, 2023 | 0 | 2 | 0 | api.fda.gov |
| Sekisui Diagnostics, LLC | San Diego, CA, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler | 4 | April 3, 2020 | 0 | 0 | 0 | api.fda.gov |
| Princeton Biomeditech Corp. | Monmouth Jct, NJ, United States | Manufacturer | 3 | December 10, 2013 | 0 | 0 | 0 | api.fda.gov |
| Princeton BioMeditech Corp. | Plainsboro, NJ, United States | Manufacturer | 3 | December 10, 2013 | 0 | 0 | 0 | api.fda.gov |
| Princeton BioMeditech Corp. | Skillman, NJ, United States | Manufacturer | 3 | December 10, 2013 | 0 | 0 | 0 | api.fda.gov |
| SA Scientific, Ltd | San Antonio, TX, United States | Manufacturer, Repackager or relabeler | 3 | July 23, 2009 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | San Diego, CA, United States | Specification developer | 2 | October 24, 2011 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Carlsbad, CA, United States | Manufacturer | 2 | October 24, 2011 | 0 | 0 | 0 | api.fda.gov |
| Quidel Corp. | San Diego, CA, United States | Complaint file establishment, Manufacturer | 2 | October 24, 2011 | 0 | 2 | 0 | api.fda.gov |
| Remel, Inc. | Lenexa, KS, United States | Manufacturer, Specification developer | 2 | August 26, 2009 | 0 | 0 | 0 | api.fda.gov |
| Abbott Diagnostics Scarborough, Inc. | Scarborough, ME, United States | Manufacturer, Manufacturer for export | 1 | April 10, 2017 | 0 | 0 | 0 | api.fda.gov |
| Abbott Diagnostics Scarborough, Inc. | Westbrook, ME, United States | Manufacturer, Manufacturer for export | 1 | April 10, 2017 | 0 | 0 | 0 | api.fda.gov |
| Boston Easy Biotech Inc | Belmont, MA, United States | Manufacturer for export, Repackager or relabeler, Specification developer | 1 | July 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer, Repackager or relabeler | 1 | July 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| Germaine Laboratories, Inc. | San Antonio, TX, United States | Manufacturer, Repackager or relabeler | 1 | January 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| Nano-Ditech Corporation | Cranbury, NJ, United States | Manufacturer | 1 | January 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| Chembio Diagnostic Systems, Inc. | Medford, NY, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chembio Diagnostic Systems | Bay Shore, NY, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keva Inc. | Blaine, WA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lumiquick Diagnostics, Inc. | Santa Clara, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scantibodies Laboratory Inc. | San Diego, CA, United States | Contract manufacturer | 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.