Devices Detecting Influenza A, B, And C Virus Antigens

PSZ 2026-01-15

Nano-Check Influenza A+B Test

Applicant Nano-Ditech Corporation

K number K252283

PSZ 2025-07-03

Innovita Flu A/B Antigen Rapid Test

Applicant Innovita (Tangshan) Biological Technology Co., Ltd.

K number K250398

PSZ 2025-04-18

Acucy® Influenza A&B Test with the Acucy® 2 System

Applicant SEKISUI Diagnostics, LLC

K number K241188

PSZ 2023-12-05

BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit

Applicant Bd

K number K232434

PSZ 2023-01-27

BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit

Applicant Bd

K number K223016

PSZ 2020-04-03

Osom Ultra Plus Flu A&B Test Kit

Applicant SEKISUI Diagnostics, LLC

K number K192719

PSZ 2020-02-18

CareStart Flu A&B Plus

Applicant Access Bio, Inc.

K number K191514

PSZ 2018-12-17

Acucy Influenza A&B Test with the Acucy System

Applicant SEKISUI Diagnostics, LLC

K number K182001

PSZ 2018-09-18

BioSign Flu A+B

K number K182157

PSZ 2018-08-08

Alere BinaxNOW Influenza A & B Card 2, Alere Reader

Applicant Alere Scarborough, Inc.

K number K181853

PSZ 2018-03-20

BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit

Applicant Bd

K number K180438

PSZ 2018-02-13

QuickVue Influenza A+B

Applicant Quidel Corporation

K number K180288

PSZ 2017-12-13

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

Applicant Alere Scarborough, Inc.

K number K173502

PSZ 2017-04-14

Sofia Influenza A+B FIA on Sofia 2

Applicant Quidel Corporation

K number K162438

PSZ 2017-04-10

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

Applicant Alere Scarborough, Inc.

K number K162642

PSZ 2016-02-25

BD Veritor System for Rapid Detection of Flu A + B Labratory Kit

Applicant Becton, Dickinson & CO

K number K160164

PSZ 2016-02-24

BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit

Applicant Becton, Dickinson & CO

K number K160161

PSZ 2016-01-12

Sofia Influenza A+B FIA

Applicant Quidel Corporation

K number K153012

PSZ 2013-12-18

ALERE INFLUENZA A & B TEST

Applicant Alere Scarborough, Inc D/B/A Binax, Inc.

K number K133637

PSZ 2013-12-10

BIOSIGN FLU A + B, STATUS FLU A & B

K number K133474

PSZ 2013-11-13

BD Veritor™ System Flu A+B Assay

Applicant Becton, Dickinson & CO

K number K133138

PSZ 2013-10-02

BD Veritor™ System Flu A+B Assay

K number K132693

PSZ 2013-09-23

BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B

K number K132692

PSZ 2013-09-09

BIOSIGN FLU A + B, STATUS FLU A & B

K number K132465

PSZ 2013-08-07

BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B

K number K132259

PSZ 2013-08-07

BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B

K number K132256

PSZ 2012-09-07

BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B

K number K121797

PSZ 2012-03-23

BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B

K number K120049

PSZ 2011-10-28

BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B

K number K112277

PSZ 2011-10-24

SOFIA ANALYZER AND INFLUENZA A+B FIA

Applicant Quidel Corp.

K number K112177

PSZ 2011-01-06

CLEARVIEW EXACT II INFLUENZA A & B TEST

Applicant Alere Scarborough, Inc D/B/A Binax, Inc.

K number K103610

PSZ 2010-11-10

BIOSIGN FLU A+B

K number K083746

PSZ 2010-06-24

BD DIRECTIGEN EX FLU A+B

K number K101461

PSZ 2010-06-14

BD DIRECTIGEN EZ FLU A+B ASSAY

Applicant Becton, Dickinson & CO

K number K101529

PSZ 2010-05-10

CLEARVIEW EXACT II INFLUENZA A & B TEST

Applicant Inverness Medical, Inc.

K number K092349

PSZ 2010-02-23

SAS FLUALERT A&B, SAS INFLUENZA A TEST

Applicant Sa Scientific, Inc.

K number K100227

PSZ 2009-10-21

MODIFICATION TO: RAMP INFLUENZA A/B ASSAY

Applicant Response Biomedical Corp.

K number K093116

PSZ 2009-09-25

OSOM INFLUENZA A&B TEST , MODEL PN190

Applicant Genzyme Corporation

K number K092633

PSZ 2009-09-15

QUICKVUE INFLUENZA A+B TEST

Applicant Quidel Corp.

K number K092698

PSZ 2009-09-11

TRU FLU, MODEL 751230

Applicant Meridian Bioscience, Inc.

K number K092553

PSZ 2009-08-26

XPECT FLU A & B

Applicant Thermo Fisher Scientific

K number K092423

PSZ 2009-08-12

MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST

Applicant Binax, Inc.

K number K092223

PSZ 2009-07-23

SAS INFLUENZA A & B TEST

Applicant Sa Scientific, Inc.

K number K080380

PSZ 2008-04-16

RAMP INFLUENZA A/B ASSAY

Applicant Response Biomedical Corp.

K number K071591

PSZ 2007-11-15

TRU FLU

Applicant Meridian Bioscience, Inc.

K number K071657

PSZ 2007-03-07

BD DIRECTIGEN EZ FLU A+B TEST

Applicant Becton, Dickinson & CO

K number K063689

PSZ 2006-11-09

BINAXNOW INFLUENZA A & B TEST

Applicant Binax, Inc.

K number K062109

PSZ 2006-06-12

OSOM INFLUENZA A&B TEST

Applicant Genzyme Corp.

K number K061508

PSZ 2006-02-21

GENZYME OSOM INFLUENZA A & B TEST

Applicant Genzyme Corp.

K number K051244

PSZ 2005-12-14

QUICKVUE INFLUENZA A + B TEST

Applicant Quidel Corp.

K number K053146

PSZ 2005-11-30

BINAXNOW INFLUENZA A & B TEST

Applicant Binax, Inc.

K number K053126

PSZ 2005-07-07

BD DIRECTIGEN EZ FLU A + B

Applicant Becton, Dickinson & CO

K number K042472

PSZ 2005-03-16

IMMUNOCARD STAT! FLU A & B

Applicant Meridian Bioscience, Inc.

K number K041626

PSZ 2004-08-10

BINAXNOW INFLUENZA A & B TEST

Applicant Binax, Inc.

K number K041049

PSZ 2004-07-22

SAS INFLUENZA A TEST

Applicant Sa Scientific, Inc.

K number K041441

PSZ 2004-07-22

SAS INFLUENZA B TEST

Applicant Sa Scientific, Inc.

K number K041439

PSZ 2003-09-11

QUICKVUE INFLUENZA A+B TEST

Applicant Quidel Corp.

K number K031899

PSZ 2003-07-17

XPECT INFLUENZA A/B

Applicant Remel, Inc.

K number K031565

PSZ 2003-03-27

FLU OIA A/B TEST KIT

Applicant Thermo Biostar, Inc.

K number K023556

PSZ 2002-09-19

BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK

Applicant Binax, Inc.

K number K021649

PSZ 2002-09-19

BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK

Applicant Binax, Inc.

K number K021646

PSZ 2001-11-30

INFLUENZA A/B RAPID TEST, CAT NO 2158 663

Applicant Roche Diagnostics Corp.

K number K011684

PSZ 2000-06-28

BD DIRECTIGEN FLU A+B

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K001364

PSZ 1999-12-20

ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST

Applicant Roche Diagnostics Corp.

K number K993048

PSZ 1999-09-24

QUICKVUE INFLUENZA A/B TEST

Applicant Quidel Corp.

K number K991633

PSZ 1998-11-25

AB FLU OIA

Applicant Biostar, Inc.

K number K981651

PSZ 1998-08-25

ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES

Applicant Zymetx, Inc.

K number K982429