Product code PSZ
- Device name
- Devices Detecting Influenza A, B, And C Virus Antigens
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3328
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K160164 | BD Veritor System for Rapid Detection of Flu A + B Labratory Kit | Becton, Dickinson & CO | 2016-02-25 |
| K160161 | BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit | Becton, Dickinson & CO | 2016-02-24 |
| K153012 | Sofia Influenza A+B FIA | Quidel Corporation | 2016-01-12 |
| K152874 | BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit | Becton, Dickinson and Co. | 2015-10-27 |
| K152870 | BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit | Becton, Dickinson and Co. | 2015-10-27 |
| K151291 | BD Veritor (TM) System for the Rapid Detection of Flu A+B | Becton, Dickinson and Company | 2015-06-10 |
| K151301 | BD Veritor™ System Flu A+B Assay | Becton, Dickinson and Company | 2015-06-08 |
| K133714 | TRU FLU | Meridian Bioscience, Inc. | 2014-01-03 |
| K133637 | ALERE INFLUENZA A & B TEST | Alere Scarborough, Inc D/B/A Binax, Inc. | 2013-12-18 |
| K133474 | BIOSIGN FLU A + B, STATUS FLU A & B | Princeton BioMeditech Corp. | 2013-12-10 |
| K133138 | BD Veritor™ System Flu A+B Assay | Becton, Dickinson & CO | 2013-11-13 |
| K132693 | BD Veritor™ System Flu A+B Assay | Becton, Dickinson and Company | 2013-10-02 |
| K132692 | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B | Becton, Dickinson and Company | 2013-09-23 |
| K132465 | BIOSIGN FLU A + B, STATUS FLU A & B | Princeton BioMeditech Corp. | 2013-09-09 |
| K132259 | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B | Becton, Dickinson and Company | 2013-08-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00695684744250 | AimStep Flu A&B Test Kit | GERMAINE LABORATORIES, INC | 2026-05-11 |
| 06970640093097 | INNOVITA | Innovita (Tangshan) Biological Technology Co., Ltd. | 2026-04-15 |
| 00742860100413 | Acucy Printer Paper | SEKISUI DIAGNOSTICS, LLC | 2026-02-27 |
| 10742860100410 | Acucy Printer Paper | SEKISUI DIAGNOSTICS, LLC | 2026-02-27 |
| 00742860100444 | Acucy Reader A/C Adapter | SEKISUI DIAGNOSTICS, LLC | 2026-02-27 |
| 00742860100475 | Acucy System Universal Drawer | SEKISUI DIAGNOSTICS, LLC | 2026-02-27 |
| 00895160002847 | Nano-Check Influenza+COVID-19 Dual Test | NANO-DITECH CORPORATION | 2024-08-08 |
| 20885380200844 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-08-02 |
| 50885380200845 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-08-02 |
| 00850056728706 | ViraDx™ SARS-CoV-2/Flu A+B Rapid Antigen Test | Lumos Diagnostics, Inc. | 2023-11-30 |
| 30848838027032 | Remel | REMEL, INC. | 2021-11-12 |
| 03848838027038 | Remel | REMEL, INC. | 2021-11-12 |
| 00848838027031 | Remel | REMEL, INC. | 2021-11-12 |
| 10743816001553 | Status™ COVID-19/Flu | PRINCETON BIOMEDITECH CORPORATION | 2021-02-15 |
| 10742860100397 | OSOM ULTRA PLUS FLU A&B Test | SEKISUI DIAGNOSTICS, LLC | 2020-06-01 |
| 00742860100406 | OSOM ULTRA PLUS FLU A&B Control Kit | SEKISUI DIAGNOSTICS, LLC | 2020-06-01 |
| 00742860100390 | OSOM ULTRA PLUS FLU A&B Test | SEKISUI DIAGNOSTICS, LLC | 2020-06-01 |
| 10811877010989 | BinaxNOW Influenza A & B Card 2 Control Swab Kit | Alere Scarborough, Inc. | 2019-07-15 |
| 10811877010972 | BinaxNOW Influenza A & B Card 2 | Alere Scarborough, Inc. | 2019-07-15 |
| 10811877010439 | ID NOW Influenza A & B Control Swab Kit | Alere Scarborough, Inc. | 2018-10-29 |
| 10811877010422 | ID NOW Influenza A & B 2 | Alere Scarborough, Inc. | 2018-10-29 |
| 00382902560715 | BD Veritor™ System CLIA-Waived Combo Pack | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 00840733101649 | ImmunoCard STAT! FLU A&B Nasopharyngeal Wash/Aspriate Kit | MERIDIAN BIOSCIENCE, INC. | 2018-03-12 |
| 00840733101656 | ImmunoCard STAT! FLU A&B | MERIDIAN BIOSCIENCE, INC. | 2018-03-12 |
| 10811877010880 | Alere Influenza A & B Control Swab Kit | Alere Scarborough, Inc. | 2018-01-01 |
| 10811877010873 | Alere Influenza A & B Test | Alere Scarborough, Inc. | 2018-01-01 |
| 10811877010194 | Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit | Alere Scarborough, Inc. | 2017-12-28 |
| 10811877010156 | Alere BinaxNOW Influenza A & B Card 2 | Alere Scarborough, Inc. | 2017-12-28 |
| 00382902560456 | BD Veritor™ System For Rapid Detection of Flu A+B CLIA-waived kit | BECTON, DICKINSON AND COMPANY | 2017-02-02 |
| 00382902560418 | BD Veritor™ System For Rapid Detection of Flu A+B Laboratory kit | BECTON, DICKINSON AND COMPANY | 2017-02-02 |