FDA Product Code
FDA Product Code PSZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.3328
510(k) Clearances — 73 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254262 | Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA | Ortho Clinical Diagnostics Inc. (QuidelOrtho) | 2026-09-04 | Dual Track | PDF ↗ |
| K252283 | Nano-Check Influenza A+B Test | Nano-Ditech Corporation | 2026-01-15 | Dual Track | PDF ↗ |
| K250398 | Innovita Flu A/B Antigen Rapid Test | Innovita (Tangshan) Biological Technology Co., Ltd. | 2025-07-03 | Traditional | PDF ↗ |
| K241188 | Acucy® Influenza A&B Test with the Acucy® 2 System | SEKISUI Diagnostics, LLC | 2025-04-18 | Dual Track | PDF ↗ |
| K232434 | BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit | Bd | 2023-12-05 | Traditional | PDF ↗ |
| K223016 | BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit | Bd | 2023-01-27 | Traditional | PDF ↗ |
| K192719 | Osom Ultra Plus Flu A&B Test Kit | SEKISUI Diagnostics, LLC | 2020-04-03 | Dual Track | PDF ↗ |
| K191514 | CareStart Flu A&B Plus | Access Bio, Inc. | 2020-02-18 | Dual Track | PDF ↗ |
| K182001 | Acucy Influenza A&B Test with the Acucy System | SEKISUI Diagnostics, LLC | 2018-12-17 | Dual Track | PDF ↗ |
| K182157 | BioSign Flu A+B | Princeton BioMeditech Corp. | 2018-09-18 | Special | PDF ↗ |
| K181853 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader | Alere Scarborough, Inc. | 2018-08-08 | Special | PDF ↗ |
| K180438 | BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit | Bd | 2018-03-20 | Special | PDF ↗ |
| K180288 | QuickVue Influenza A+B | Quidel Corporation | 2018-02-13 | Special | PDF ↗ |
| 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 | Special | PDF ↗ |
| K162438 | Sofia Influenza A+B FIA on Sofia 2 | Quidel Corporation | 2017-04-14 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K160164 | BD Veritor System for Rapid Detection of Flu A + B Labratory Kit | Becton, Dickinson & CO | 2016-02-25 | Special | PDF ↗ |
| K160161 | BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit | Becton, Dickinson & CO | 2016-02-24 | Special | PDF ↗ |
| K153012 | Sofia Influenza A+B FIA | Quidel Corporation | 2016-01-12 | Traditional | PDF ↗ |
| K152870 | BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit | Becton, Dickinson and Co. | 2015-10-27 | Special | PDF ↗ |
| K152874 | BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit | Becton, Dickinson and Co. | 2015-10-27 | Special | PDF ↗ |
| K151291 | BD Veritor (TM) System for the Rapid Detection of Flu A+B | Becton, Dickinson and Company | 2015-06-10 | Special | PDF ↗ |
| K151301 | BD Veritor System Flu A+B Assay | Becton, Dickinson and Company | 2015-06-08 | Special | PDF ↗ |
| K133714 | TRU FLU | Meridian Bioscience, Inc. | 2014-01-03 | Special | PDF ↗ |
| K133637 | ALERE INFLUENZA A & B TEST | Alere Scarborough, Inc D/B/A Binax, Inc. | 2013-12-18 | Special | PDF ↗ |
| K133474 | BIOSIGN FLU A + B, STATUS FLU A & B | Princeton BioMeditech Corp. | 2013-12-10 | Special | PDF ↗ |
| K133138 | BD Veritor System Flu A+B Assay | Becton, Dickinson & CO | 2013-11-13 | Special | PDF ↗ |
| K132693 | BD Veritor System Flu A+B Assay | Becton, Dickinson and Company | 2013-10-02 | Special | PDF ↗ |
| K132692 | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B | Becton, Dickinson and Company | 2013-09-23 | Special | PDF ↗ |
| K132465 | BIOSIGN FLU A + B, STATUS FLU A & B | Princeton BioMeditech Corp. | 2013-09-09 | Special | PDF ↗ |
| K132259 | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B | Becton, Dickinson and Company | 2013-08-07 | Special | PDF ↗ |
| K132256 | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B | Becton, Dickinson and Company | 2013-08-07 | Special | PDF ↗ |
| K121797 | BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B | Becton, Dickinson and Company | 2012-09-07 | Traditional | PDF ↗ |
| K120049 | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B | Becton, Dickinson and Company | 2012-03-23 | Traditional | PDF ↗ |
| K112277 | BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B | Becton, Dickinson and Company | 2011-10-28 | Traditional | PDF ↗ |
| K112177 | SOFIA ANALYZER AND INFLUENZA A+B FIA | Quidel Corp. | 2011-10-24 | Traditional | PDF ↗ |
| K103610 | CLEARVIEW EXACT II INFLUENZA A & B TEST | Alere Scarborough, Inc D/B/A Binax, Inc. | 2011-01-06 | Special | PDF ↗ |
| K083746 | BIOSIGN FLU A+B | Princeton BioMeditech Corp. | 2010-11-10 | Traditional | PDF ↗ |
| K101461 | BD DIRECTIGEN EX FLU A+B | Becton, Dickinson and Company | 2010-06-24 | Special | PDF ↗ |
| K101529 | BD DIRECTIGEN EZ FLU A+B ASSAY | Becton, Dickinson & CO | 2010-06-14 | Special | PDF ↗ |
| K092349 | CLEARVIEW EXACT II INFLUENZA A & B TEST | Inverness Medical, Inc. | 2010-05-10 | Traditional | PDF ↗ |
| K100227 | SAS FLUALERT A&B, SAS INFLUENZA A TEST | Sa Scientific, Inc. | 2010-02-23 | Special | PDF ↗ |
| K093116 | MODIFICATION TO: RAMP INFLUENZA A/B ASSAY | Response Biomedical Corp. | 2009-10-21 | Special | PDF ↗ |
| K092633 | OSOM INFLUENZA A&B TEST , MODEL PN190 | Genzyme Corporation | 2009-09-25 | Special | PDF ↗ |
| K092698 | QUICKVUE INFLUENZA A+B TEST | Quidel Corp. | 2009-09-15 | Special | PDF ↗ |
| K092553 | TRU FLU, MODEL 751230 | Meridian Bioscience, Inc. | 2009-09-11 | Special | PDF ↗ |
| K092423 | XPECT FLU A & B | Thermo Fisher Scientific | 2009-08-26 | Special | PDF ↗ |
| K092223 | MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST | Binax, Inc. | 2009-08-12 | Special | PDF ↗ |
| K080380 | SAS INFLUENZA A & B TEST | Sa Scientific, Inc. | 2009-07-23 | Traditional | PDF ↗ |
| K071591 | RAMP INFLUENZA A/B ASSAY | Response Biomedical Corp. | 2008-04-16 | Traditional | PDF ↗ |
| K071657 | TRU FLU | Meridian Bioscience, Inc. | 2007-11-15 | Traditional | PDF ↗ |
| K063689 | BD DIRECTIGEN EZ FLU A+B TEST | Becton, Dickinson & CO | 2007-03-07 | Traditional | PDF ↗ |
| K062109 | BINAXNOW INFLUENZA A & B TEST | Binax, Inc. | 2006-11-09 | Traditional | PDF ↗ |
| K061508 | OSOM INFLUENZA A&B TEST | Genzyme Corp. | 2006-06-12 | Traditional | PDF ↗ |
| K051244 | GENZYME OSOM INFLUENZA A & B TEST | Genzyme Corp. | 2006-02-21 | Traditional | PDF ↗ |
| K053146 | QUICKVUE INFLUENZA A + B TEST | Quidel Corp. | 2005-12-14 | Traditional | PDF ↗ |
| K053126 | BINAXNOW INFLUENZA A & B TEST | Binax, Inc. | 2005-11-30 | Traditional | PDF ↗ |
| K042472 | BD DIRECTIGEN EZ FLU A + B | Becton, Dickinson & CO | 2005-07-07 | Traditional | PDF ↗ |
| K041626 | IMMUNOCARD STAT! FLU A & B | Meridian Bioscience, Inc. | 2005-03-16 | Traditional | PDF ↗ |
| K041049 | BINAXNOW INFLUENZA A & B TEST | Binax, Inc. | 2004-08-10 | Traditional | PDF ↗ |
| K041441 | SAS INFLUENZA A TEST | Sa Scientific, Inc. | 2004-07-22 | Traditional | PDF ↗ |
| K041439 | SAS INFLUENZA B TEST | Sa Scientific, Inc. | 2004-07-22 | Traditional | PDF ↗ |
| K031899 | QUICKVUE INFLUENZA A+B TEST | Quidel Corp. | 2003-09-11 | Traditional | PDF ↗ |
| K031565 | XPECT INFLUENZA A/B | Remel, Inc. | 2003-07-17 | Traditional | PDF ↗ |
| K023556 | FLU OIA A/B TEST KIT | Thermo Biostar, Inc. | 2003-03-27 | Traditional | PDF ↗ |
| K021646 | BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK | Binax, Inc. | 2002-09-19 | Traditional | PDF ↗ |
| K021649 | BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK | Binax, Inc. | 2002-09-19 | Traditional | PDF ↗ |
| K011684 | INFLUENZA A/B RAPID TEST, CAT NO 2158 663 | Roche Diagnostics Corp. | 2001-11-30 | Traditional | PDF ↗ |
| K001364 | BD DIRECTIGEN FLU A+B | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2000-06-28 | Traditional | PDF ↗ |
| K993048 | ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST | Roche Diagnostics Corp. | 1999-12-20 | Traditional | PDF ↗ |
| K991633 | QUICKVUE INFLUENZA A/B TEST | Quidel Corp. | 1999-09-24 | Traditional | PDF ↗ |
| K981651 | AB FLU OIA | Biostar, Inc. | 1998-11-25 | Traditional | PDF ↗ |
| K982429 | ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES | Zymetx, Inc. | 1998-08-25 | Traditional | PDF ↗ |
Product code PSZ · Class II · Microbiology. Data: openFDA.