PSZ · Class II · 21 CFR 866.3328

FDA Product Code PSZ: Devices Detecting Influenza A, B, And C Virus Antigens

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.

Leading manufacturers include Becton, Dickinson and Company, Binax, Inc. and Becton, Dickinson & CO.

73
Total
73
Cleared
109d
Avg days
1998
Since
73 devices
25–48 of 73
Cleared Dec 18, 2013
ALERE INFLUENZA A & B TEST
K133637
Alere Scarborough, Inc D/B/A Binax, Inc.
Microbiology · 41d
Cleared Dec 10, 2013
BIOSIGN FLU A + B, STATUS FLU A & B
K133474
Princeton BioMeditech Corp.
Microbiology · 28d
Cleared Nov 13, 2013
BD Veritor™ System Flu A+B Assay
K133138
Becton, Dickinson & CO
Microbiology · 27d
Cleared Oct 02, 2013
BD Veritor™ System Flu A+B Assay
K132693
Becton, Dickinson and Company
Microbiology · 34d
Cleared Sep 23, 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K132692
Becton, Dickinson and Company
Microbiology · 25d
Cleared Sep 09, 2013
BIOSIGN FLU A + B, STATUS FLU A & B
K132465
Princeton BioMeditech Corp.
Microbiology · 33d
Cleared Aug 07, 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K132256
Becton, Dickinson and Company
Microbiology · 19d
Cleared Aug 07, 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K132259
Becton, Dickinson and Company
Microbiology · 19d
Cleared Sep 07, 2012
BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
K121797
Becton, Dickinson and Company
Microbiology · 80d
Cleared Mar 23, 2012
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K120049
Becton, Dickinson and Company
Microbiology · 77d
Cleared Oct 28, 2011
BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
K112277
Becton, Dickinson and Company
Microbiology · 80d
Cleared Oct 24, 2011
SOFIA ANALYZER AND INFLUENZA A+B FIA
K112177
Quidel Corp.
Microbiology · 88d
Cleared Jan 06, 2011
CLEARVIEW EXACT II INFLUENZA A & B TEST
K103610
Alere Scarborough, Inc D/B/A Binax, Inc.
Microbiology · 28d
Cleared Nov 10, 2010
BIOSIGN FLU A+B
K083746
Princeton BioMeditech Corp.
Microbiology · 693d
Cleared Jun 24, 2010
BD DIRECTIGEN EX FLU A+B
K101461
Becton, Dickinson and Company
Microbiology · 29d
Cleared Jun 14, 2010
BD DIRECTIGEN EZ FLU A+B ASSAY
K101529
Becton, Dickinson & CO
Microbiology · 12d
Cleared May 10, 2010
CLEARVIEW EXACT II INFLUENZA A & B TEST
K092349
Inverness Medical, Inc.
Microbiology · 279d
Cleared Feb 23, 2010
SAS FLUALERT A&B, SAS INFLUENZA A TEST
K100227
Sa Scientific, Inc.
Microbiology · 28d
Cleared Oct 21, 2009
MODIFICATION TO: RAMP INFLUENZA A/B ASSAY
K093116
Response Biomedical Corp.
Microbiology · 19d
Cleared Sep 25, 2009
OSOM INFLUENZA A&B TEST , MODEL PN190
K092633
Genzyme Corporation
Microbiology · 29d
Cleared Sep 15, 2009
QUICKVUE INFLUENZA A+B TEST
K092698
Quidel Corp.
Microbiology · 13d
Cleared Sep 11, 2009
TRU FLU, MODEL 751230
K092553
Meridian Bioscience, Inc.
Microbiology · 22d
Cleared Aug 26, 2009
XPECT FLU A & B
K092423
Thermo Fisher Scientific
Microbiology · 19d
Cleared Aug 12, 2009
MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST
K092223
Binax, Inc.
Microbiology · 20d