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, Becton, Dickinson & CO and Binax, Inc..

73
Total
73
Cleared
109d
Avg days
1998
Since
73 devices
49–72 of 73
Cleared Jul 23, 2009
SAS INFLUENZA A & B TEST
K080380
Sa Scientific, Inc.
Microbiology · 526d
Cleared Apr 16, 2008
RAMP INFLUENZA A/B ASSAY
K071591
Response Biomedical Corp.
Microbiology · 310d
Cleared Nov 15, 2007
TRU FLU
K071657
Meridian Bioscience, Inc.
Microbiology · 150d
Cleared Mar 07, 2007
BD DIRECTIGEN EZ FLU A+B TEST
K063689
Becton, Dickinson & CO
Microbiology · 85d
Cleared Nov 09, 2006
BINAXNOW INFLUENZA A & B TEST
K062109
Binax, Inc.
Microbiology · 108d
Cleared Jun 12, 2006
OSOM INFLUENZA A&B TEST
K061508
Genzyme Corp.
Microbiology · 11d
Cleared Feb 21, 2006
GENZYME OSOM INFLUENZA A & B TEST
K051244
Genzyme Corp.
Microbiology · 281d
Cleared Dec 14, 2005
QUICKVUE INFLUENZA A + B TEST
K053146
Quidel Corp.
Microbiology · 34d
Cleared Nov 30, 2005
BINAXNOW INFLUENZA A & B TEST
K053126
Binax, Inc.
Microbiology · 23d
Cleared Jul 07, 2005
BD DIRECTIGEN EZ FLU A + B
K042472
Becton, Dickinson & CO
Microbiology · 300d
Cleared Mar 16, 2005
IMMUNOCARD STAT! FLU A & B
K041626
Meridian Bioscience, Inc.
Microbiology · 273d
Cleared Aug 10, 2004
BINAXNOW INFLUENZA A & B TEST
K041049
Binax, Inc.
Microbiology · 110d
Cleared Jul 22, 2004
SAS INFLUENZA B TEST
K041439
Sa Scientific, Inc.
Microbiology · 51d
Cleared Jul 22, 2004
SAS INFLUENZA A TEST
K041441
Sa Scientific, Inc.
Microbiology · 51d
Cleared Sep 11, 2003
QUICKVUE INFLUENZA A+B TEST
K031899
Quidel Corp.
Microbiology · 99d
Cleared Jul 17, 2003
XPECT INFLUENZA A/B
K031565
Remel, Inc.
Microbiology · 59d
Cleared Mar 27, 2003
FLU OIA A/B TEST KIT
K023556
Thermo Biostar, Inc.
Microbiology · 155d
Cleared Sep 19, 2002
BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK
K021646
Binax, Inc.
Microbiology · 122d
Cleared Sep 19, 2002
BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK
K021649
Binax, Inc.
Microbiology · 122d
Cleared Nov 30, 2001
INFLUENZA A/B RAPID TEST, CAT NO 2158 663
K011684
Roche Diagnostics Corp.
Microbiology · 184d
Cleared Jun 28, 2000
BD DIRECTIGEN FLU A+B
K001364
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 58d
Cleared Dec 20, 1999
ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST
K993048
Roche Diagnostics Corp.
Microbiology · 101d
Cleared Sep 24, 1999
QUICKVUE INFLUENZA A/B TEST
K991633
Quidel Corp.
Microbiology · 135d
Cleared Nov 25, 1998
AB FLU OIA
K981651
Biostar, Inc.
Microbiology · 198d