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 Quidel Corp..

72
Total
72
Cleared
107d
Avg days
1998
Since
72 devices
25–48 of 72
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 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 Feb 23, 2010
SAS FLUALERT A&B, SAS INFLUENZA A TEST
K100227
Sa Scientific, Inc.
Microbiology · 28d
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 Jul 23, 2009
SAS INFLUENZA A & B TEST
K080380
Sa Scientific, Inc.
Microbiology · 526d
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 Dec 14, 2005
QUICKVUE INFLUENZA A + B TEST
K053146
Quidel Corp.
Microbiology · 34d
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 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 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