| K252283 | Nano-Check Influenza A+B Test | Nano-Ditech Corporation | 2026-01-15 |
| K250398 | Innovita Flu A/B Antigen Rapid Test | Innovita (Tangshan) Biological Technology Co., Ltd. | 2025-07-03 |
| K241188 | Acucy® Influenza A&B Test with the Acucy® 2 System | SEKISUI Diagnostics, LLC | 2025-04-18 |
| K232434 | BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit | Bd | 2023-12-05 |
| K223016 | BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit | Bd | 2023-01-27 |
| K192719 | Osom Ultra Plus Flu A&B Test Kit | SEKISUI Diagnostics, LLC | 2020-04-03 |
| K191514 | CareStart Flu A&B Plus | Access Bio, Inc. | 2020-02-18 |
| K182001 | Acucy Influenza A&B Test with the Acucy System | SEKISUI Diagnostics, LLC | 2018-12-17 |
| K182157 | BioSign Flu A+B | Princeton BioMeditech Corp. | 2018-09-18 |
| K181853 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader | Alere Scarborough, Inc. | 2018-08-08 |
| K180438 | BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit | Bd | 2018-03-20 |
| K180288 | QuickVue Influenza A+B | Quidel Corporation | 2018-02-13 |
| K173502 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit | Alere Scarborough, Inc. | 2017-12-13 |
| K162438 | Sofia Influenza A+B FIA on Sofia 2 | Quidel Corporation | 2017-04-14 |
| K162642 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit | Alere Scarborough, Inc. | 2017-04-10 |