PSZ — Devices Detecting Influenza A, B, And C Virus Antigens Class II
Classification Details
- Product Code
- PSZ
- Device Class
- Class II
- Regulation Number
- 866.3328
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252283 | nano-ditech corporation | Nano-Check Influenza A+B Test | January 15, 2026 |
| K250398 | innovita (tangshan) biological technology co | Innovita Flu A/B Antigen Rapid Test | July 3, 2025 |
| K241188 | sekisui diagnostics | Acucy® Influenza A&B Test with the Acucy® 2 System | April 18, 2025 |
| K232434 | bd | BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit | December 5, 2023 |
| K223016 | bd | BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit | January 27, 2023 |
| K192719 | sekisui diagnostics | Osom Ultra Plus Flu A&B Test Kit | April 3, 2020 |
| K191514 | access bio | CareStart Flu A&B Plus | February 18, 2020 |
| K182001 | sekisui diagnostics | Acucy Influenza A&B Test with the Acucy System | December 17, 2018 |
| K182157 | princeton biomeditech | BioSign Flu A+B | September 18, 2018 |
| K181853 | alere scarborough | Alere BinaxNOW Influenza A & B Card 2, Alere Reader | August 8, 2018 |
| K180438 | bd | BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit | March 20, 2018 |
| K180288 | quidel corporation | QuickVue Influenza A+B | February 13, 2018 |
| K173502 | alere scarborough | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A | December 13, 2017 |
| K162438 | quidel corporation | Sofia Influenza A+B FIA on Sofia 2 | April 14, 2017 |
| K162642 | alere scarborough | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A | April 10, 2017 |
| K160164 | becton, dickinson and | BD Veritor System for Rapid Detection of Flu A + B Labratory Kit | February 25, 2016 |
| K160161 | becton, dickinson and | BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit | February 24, 2016 |
| K153012 | quidel corporation | Sofia Influenza A+B FIA | January 12, 2016 |
| K152874 | becton, dickinson and | BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit | October 27, 2015 |
| K152870 | becton, dickinson and | BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit | October 27, 2015 |