| Nano-Check Influenza A+B Test (K252283) | Nano-Ditech Corporation | 2026-01-15 |
| Innovita Flu A/B Antigen Rapid Test (K250398) | Innovita (Tangshan) Biological Technology Co., Ltd. | 2025-07-03 |
| Acucy® Influenza A&B Test with the Acucy® 2 System (K241188) | SEKISUI Diagnostics, LLC | 2025-04-18 |
| BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit (K232434) | Bd | 2023-12-05 |
| BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit (K223016) | Bd | 2023-01-27 |
| Osom Ultra Plus Flu A&B Test Kit (K192719) | SEKISUI Diagnostics, LLC | 2020-04-03 |
| CareStart Flu A&B Plus (K191514) | Access Bio, Inc. | 2020-02-18 |
| Acucy Influenza A&B Test with the Acucy System (K182001) | SEKISUI Diagnostics, LLC | 2018-12-17 |
| BioSign Flu A+B (K182157) | Princeton BioMeditech Corp. | 2018-09-18 |
| Alere BinaxNOW Influenza A & B Card 2, Alere Reader (K181853) | Alere Scarborough, Inc. | 2018-08-08 |
| BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit (K180438) | Bd | 2018-03-20 |
| QuickVue Influenza A+B (K180288) | Quidel Corporation | 2018-02-13 |
| Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit (K173502) | Alere Scarborough, Inc. | 2017-12-13 |
| Sofia Influenza A+B FIA on Sofia 2 (K162438) | Quidel Corporation | 2017-04-14 |
| Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit (K162642) | Alere Scarborough, Inc. | 2017-04-10 |
| BD Veritor System for Rapid Detection of Flu A + B Labratory Kit (K160164) | Becton, Dickinson & CO | 2016-02-25 |
| BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit (K160161) | Becton, Dickinson & CO | 2016-02-24 |
| Sofia Influenza A+B FIA (K153012) | Quidel Corporation | 2016-01-12 |
| BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit (K152870) | Becton, Dickinson and Co. | 2015-10-27 |
| BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit (K152874) | Becton, Dickinson and Co. | 2015-10-27 |
| BD Veritor (TM) System for the Rapid Detection of Flu A+B (K151291) | Becton, Dickinson and Company | 2015-06-10 |
| BD Veritor™ System Flu A+B Assay (K151301) | Becton, Dickinson and Company | 2015-06-08 |
| TRU FLU (K133714) | Meridian Bioscience, Inc. | 2014-01-03 |
| ALERE INFLUENZA A & B TEST (K133637) | Alere Scarborough, Inc D/B/A Binax, Inc. | 2013-12-18 |
| BIOSIGN FLU A + B, STATUS FLU A & B (K133474) | Princeton BioMeditech Corp. | 2013-12-10 |
| BD Veritor™ System Flu A+B Assay (K133138) | Becton, Dickinson & CO | 2013-11-13 |
| BD Veritor™ System Flu A+B Assay (K132693) | Becton, Dickinson and Company | 2013-10-02 |
| BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B (K132692) | Becton, Dickinson and Company | 2013-09-23 |
| BIOSIGN FLU A + B, STATUS FLU A & B (K132465) | Princeton BioMeditech Corp. | 2013-09-09 |
| BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B (K132256) | Becton, Dickinson and Company | 2013-08-07 |
| BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B (K132259) | Becton, Dickinson and Company | 2013-08-07 |
| BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B (K121797) | Becton, Dickinson and Company | 2012-09-07 |
| BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B (K120049) | Becton, Dickinson and Company | 2012-03-23 |
| BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B (K112277) | Becton, Dickinson and Company | 2011-10-28 |
| SOFIA ANALYZER AND INFLUENZA A+B FIA (K112177) | Quidel Corp. | 2011-10-24 |
| CLEARVIEW EXACT II INFLUENZA A & B TEST (K103610) | Alere Scarborough, Inc D/B/A Binax, Inc. | 2011-01-06 |
| BIOSIGN FLU A+B (K083746) | Princeton BioMeditech Corp. | 2010-11-10 |
| BD DIRECTIGEN EX FLU A+B (K101461) | Becton, Dickinson and Company | 2010-06-24 |
| BD DIRECTIGEN EZ FLU A+B ASSAY (K101529) | Becton, Dickinson & CO | 2010-06-14 |
| CLEARVIEW EXACT II INFLUENZA A & B TEST (K092349) | Inverness Medical, Inc. | 2010-05-10 |
| SAS FLUALERT A&B, SAS INFLUENZA A TEST (K100227) | Sa Scientific, Inc. | 2010-02-23 |
| MODIFICATION TO: RAMP INFLUENZA A/B ASSAY (K093116) | Response Biomedical Corp. | 2009-10-21 |
| OSOM INFLUENZA A&B TEST , MODEL PN190 (K092633) | Genzyme Corporation | 2009-09-25 |
| QUICKVUE INFLUENZA A+B TEST (K092698) | Quidel Corp. | 2009-09-15 |
| TRU FLU, MODEL 751230 (K092553) | Meridian Bioscience, Inc. | 2009-09-11 |
| XPECT FLU A & B (K092423) | Thermo Fisher Scientific | 2009-08-26 |
| MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST (K092223) | Binax, Inc. | 2009-08-12 |
| SAS INFLUENZA A & B TEST (K080380) | Sa Scientific, Inc. | 2009-07-23 |
| RAMP INFLUENZA A/B ASSAY (K071591) | Response Biomedical Corp. | 2008-04-16 |
| TRU FLU (K071657) | Meridian Bioscience, Inc. | 2007-11-15 |
| BD DIRECTIGEN EZ FLU A+B TEST (K063689) | Becton, Dickinson & CO | 2007-03-07 |
| BINAXNOW INFLUENZA A & B TEST (K062109) | Binax, Inc. | 2006-11-09 |
| OSOM INFLUENZA A&B TEST (K061508) | Genzyme Corp. | 2006-06-12 |
| GENZYME OSOM INFLUENZA A & B TEST (K051244) | Genzyme Corp. | 2006-02-21 |
| QUICKVUE INFLUENZA A + B TEST (K053146) | Quidel Corp. | 2005-12-14 |
| BINAXNOW INFLUENZA A & B TEST (K053126) | Binax, Inc. | 2005-11-30 |
| BD DIRECTIGEN EZ FLU A + B (K042472) | Becton, Dickinson & CO | 2005-07-07 |
| IMMUNOCARD STAT! FLU A & B (K041626) | Meridian Bioscience, Inc. | 2005-03-16 |
| BINAXNOW INFLUENZA A & B TEST (K041049) | Binax, Inc. | 2004-08-10 |
| SAS INFLUENZA A TEST (K041441) | Sa Scientific, Inc. | 2004-07-22 |
| SAS INFLUENZA B TEST (K041439) | Sa Scientific, Inc. | 2004-07-22 |
| QUICKVUE INFLUENZA A+B TEST (K031899) | Quidel Corp. | 2003-09-11 |
| XPECT INFLUENZA A/B (K031565) | Remel, Inc. | 2003-07-17 |
| FLU OIA A/B TEST KIT (K023556) | Thermo Biostar, Inc. | 2003-03-27 |
| BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK (K021646) | Binax, Inc. | 2002-09-19 |
| BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK (K021649) | Binax, Inc. | 2002-09-19 |
| INFLUENZA A/B RAPID TEST, CAT NO 2158 663 (K011684) | Roche Diagnostics Corp. | 2001-11-30 |
| BD DIRECTIGEN FLU A+B (K001364) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2000-06-28 |
| ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST (K993048) | Roche Diagnostics Corp. | 1999-12-20 |
| QUICKVUE INFLUENZA A/B TEST (K991633) | Quidel Corp. | 1999-09-24 |
| AB FLU OIA (K981651) | Biostar, Inc. | 1998-11-25 |
| ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES (K982429) | Zymetx, Inc. | 1998-08-25 |