PSZ — Devices Detecting Influenza A, B, And C Virus Antigens Class II
FDA product code PSZ covers "Devices Detecting Influenza A, B, And C Virus Antigens", a Class II medical device regulated under 21 CFR 866.3328. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
| K152870 | becton, dickinson and | BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit | October 27, 2015 |
| K152874 | becton, dickinson and | BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit | October 27, 2015 |