Panels › Microbiology › Product code PSZ · Class 2
Devices Detecting Influenza A, B, And C Virus Antigens
Regulation 866.3328
2510(k)s in 12 months (73 all time)
0recalls in 12 months (5 all time)
4recalls that name a 510(k)
Top companies in PSZ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 4, 2026 | K254262 | Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA Ortho Clinical Diagnostics Inc. (QuidelOrtho) | PSZ |
| Jan 15, 2026 | K252283 | Nano-Check Influenza A+B Test Nano-Ditech Corporation | PSZ |
| Jul 3, 2025 | K250398 | Innovita Flu A/B Antigen Rapid Test Innovita (Tangshan) Biological Technology Co., Ltd., CN | PSZ |
| Apr 18, 2025 | K241188 | Acucy® Influenza A&B Test with the Acucy® 2 System SEKISUI Diagnostics, LLC | PSZ |
| Dec 5, 2023 | K232434 | BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit Bd | PSZ |
| Jan 27, 2023 | K223016 | BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit Bd | PSZ |
| Apr 3, 2020 | K192719 | Osom Ultra Plus Flu A&B Test Kit SEKISUI Diagnostics, LLC | PSZ |
| Feb 18, 2020 | K191514 | CareStart Flu A&B Plus Access Bio, Inc. | PSZ |
| Dec 17, 2018 | K182001 | Acucy Influenza A&B Test with the Acucy System SEKISUI Diagnostics, LLC | PSZ |
| Sep 18, 2018 | K182157 | BioSign Flu A+B Princeton BioMeditech Corp. | PSZ |
| Aug 8, 2018 | K181853 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader Alere Scarborough, Inc. | PSZ |
| Mar 20, 2018 | K180438 | BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit Bd | PSZ |
| Feb 13, 2018 | K180288 | QuickVue Influenza A+B Quidel Corporation | PSZ |
| Dec 13, 2017 | K173502 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit Alere Scarborough, Inc. | PSZ |
| Apr 14, 2017 | K162438 | Sofia Influenza A+B FIA on Sofia 2 Quidel Corporation | PSZ |
| Apr 10, 2017 | K162642 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit Alere Scarborough, Inc. | PSZ |
| Feb 25, 2016 | K160164 | BD Veritor System for Rapid Detection of Flu A + B Labratory Kit Becton, Dickinson & CO | PSZ |
| Feb 24, 2016 | K160161 | BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit Becton, Dickinson & CO | PSZ |
| Jan 12, 2016 | K153012 | Sofia Influenza A+B FIA Quidel Corporation | PSZ |
| Oct 27, 2015 | K152874 | BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit Becton, Dickinson and Co. | PSZ |
| Oct 27, 2015 | K152870 | BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit Becton, Dickinson and Co. | PSZ |
| Jun 10, 2015 | K151291 | BD Veritor (TM) System for the Rapid Detection of Flu A+B Becton, Dickinson and Company | PSZ |
| Jun 8, 2015 | K151301 | BD Veritor System Flu A+B Assay Becton, Dickinson and Company | PSZ |
| Jan 3, 2014 | K133714 | TRU FLU Meridian Bioscience, Inc. | PSZ |
| Dec 18, 2013 | K133637 | ALERE INFLUENZA A & B TEST Alere Scarborough, Inc D/B/A Binax, Inc. | PSZ |
| Dec 10, 2013 | K133474 | BIOSIGN FLU A + B, STATUS FLU A & B Princeton BioMeditech Corp. | PSZ |
| Nov 13, 2013 | K133138 | BD Veritor System Flu A+B Assay Becton, Dickinson & CO | PSZ |
| Oct 2, 2013 | K132693 | BD Veritor System Flu A+B Assay Becton, Dickinson and Company | PSZ |
| Sep 23, 2013 | K132692 | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B Becton, Dickinson and Company | PSZ |
| Sep 9, 2013 | K132465 | BIOSIGN FLU A + B, STATUS FLU A & B Princeton BioMeditech Corp. | PSZ |
| Aug 7, 2013 | K132259 | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B Becton, Dickinson and Company | PSZ |
| Aug 7, 2013 | K132256 | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B Becton, Dickinson and Company | PSZ |
| Sep 7, 2012 | K121797 | BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B Becton, Dickinson and Company | PSZ |
| Mar 23, 2012 | K120049 | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B Becton, Dickinson and Company | PSZ |
| Oct 28, 2011 | K112277 | BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B Becton, Dickinson and Company | PSZ |
| Oct 24, 2011 | K112177 | SOFIA ANALYZER AND INFLUENZA A+B FIA Quidel Corp. | PSZ |
| Jan 6, 2011 | K103610 | CLEARVIEW EXACT II INFLUENZA A & B TEST Alere Scarborough, Inc D/B/A Binax, Inc. | PSZ |
| Nov 10, 2010 | K083746 | BIOSIGN FLU A+B Princeton BioMeditech Corp. | PSZ |
| Jun 24, 2010 | K101461 | BD DIRECTIGEN EX FLU A+B Becton, Dickinson and Company | PSZ |
| Jun 14, 2010 | K101529 | BD DIRECTIGEN EZ FLU A+B ASSAY Becton, Dickinson & CO | PSZ |
| May 10, 2010 | K092349 | CLEARVIEW EXACT II INFLUENZA A & B TEST Inverness Medical, Inc. | PSZ |
| Feb 23, 2010 | K100227 | SAS FLUALERT A&B, SAS INFLUENZA A TEST Sa Scientific, Inc. | PSZ |
| Oct 21, 2009 | K093116 | MODIFICATION TO: RAMP INFLUENZA A/B ASSAY Response Biomedical Corp., CA | PSZ |
| Sep 25, 2009 | K092633 | OSOM INFLUENZA A&B TEST , MODEL PN190 Genzyme Corporation | PSZ |
| Sep 15, 2009 | K092698 | QUICKVUE INFLUENZA A+B TEST Quidel Corp. | PSZ |
| Sep 11, 2009 | K092553 | TRU FLU, MODEL 751230 Meridian Bioscience, Inc. | PSZ |
| Aug 26, 2009 | K092423 | XPECT FLU A & B Thermo Fisher Scientific | PSZ |
| Aug 12, 2009 | K092223 | MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST Binax, Inc. | PSZ |
| Jul 23, 2009 | K080380 | SAS INFLUENZA A & B TEST Sa Scientific, Inc. | PSZ |
| Apr 16, 2008 | K071591 | RAMP INFLUENZA A/B ASSAY Response Biomedical Corp., CA | PSZ |
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