Product Code: GTY


Products Classified as GTY

3325Antigens, All Groups, Streptococcus Spp.Streptococcus Spp. Serological Reagents.

Total Product Life Cycle (TPLC) Devices

3325Antigens, All Groups, Streptococcus Spp.Streptococcus Spp. Serological Reagents.

Pre-market Notifications for GTY

K212623Healgen Strep A Rapid Test Strip (Throat Swab)Healgen Scientific, LLC
K171976Sofia Strep A+ FIA, Sofia 2 AnalyzerQuidel Corporation
K141775SOFIA (R) STREP A+ FIAQUIDEL CORPORATION
K133343WONDFO RAPID STREP A TESTGuangzhou Wondfo Biotech Co., Ltd.
K123793SOFIA STREP A FIAQUIDEL CORPORATION
K122718BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREPBecton, Dickinson And Company
K091489CLEARVIEW ADVANCED STREP A , MODEL 737-430BINAX, INC.
K082661BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP APRINCETON BIOMEDITECH CORP.
K051638INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBCUNIPATH LTD.
K040708STATUS FIRST STREP APRINCETON BIOMEDITECH CORP.
K031784ACON STREP A RAPID TEST DEVICEACON LABORATORIES, INC.
K023766ACON STREP A TWIST TEST DEVICEACON LABORATORIES CO.
K023270SAS STREPALERTSA SCIENTIFIC, INC.
K011097QUICKVUE DIPSTICK STREP AQUIDEL CORP.
K010582ACON STREP A RAPID TEST STRIPACON LABORATORIES CO.

Global Unique Device Identification Database

00382902560746ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
00382902560715ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
00382902560401ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
00613647000557ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
20613647000292ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
00695684730406Antigens, All Groups, Streptococcus Spp.
00657498600023Antigens, All Groups, Streptococcus Spp.
00657498600016Antigens, All Groups, Streptococcus Spp.
00742860100116ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
00742860001499ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
00742860001475ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
00722066000014Antigens, All Groups, Streptococcus Spp.
10816862021056Antigens, All Groups, Streptococcus Spp.
00855574005438Antigens, All Groups, Streptococcus Spp.
00855574005421Antigens, All Groups, Streptococcus Spp.

Maude Adverse Events

CONSULT STREP A DIPSTICK 5003 25TALERE SAN DIEGO2019-08-21
HENRY SCHEIN STREP A DIPSTICK 25TALERE SAN DIEGO, INC.2019-06-19
CONSULT DIAGNOSTICS STREP A DIPSTICK KITALERE SAN DIEGO, INC.2019-03-11
PRO ADVANTAGE STREP A DIPSTICK (25T)ALERE SAN DIEGO, INC.2019-02-20
PRO ADVANTAGE STREP A DIPSTICK (25T)ALERE SAN DIEGO, INC.2019-02-20
PRO ADVANTAGE STREP A DIPSTICK (25T)ALERE SAN DIEGO, INC.2019-02-20
STREP A RAPID TEST STRIP (THROAT SWAB)ALERE SAN DIEGO, INC.2018-12-10
MEDLINE STREP A TEST STRIPALERE SAN DIEGO, INC2018-07-25
MEDLINE STREP A TEST STRIPALERE SAN DIEGO, INC2018-07-25
MEDLINE STREP A TEST STRIPALERE SAN DIEGO, INC2018-07-25
MEDLINE STREP A TEST STRIPALERE SAN DIEGO, INC2018-07-25
MEDLINE STREP A TEST STRIPALERE SAN DIEGO, INC2018-07-25
CONSULT STREP A DIPSTICK 5003 25TALERE SAN DIEGO, INC2018-07-12
CONSULT STREP A DIPSTICK 5003 25TALERE SAN DIEGO, INC2018-07-12
CONSULT STREP A DIPSTICK 5003 25TALERE SAN DIEGO, INC2018-06-29
CONSULT STREP A DIPSTICK 5003 25TALERE SAN DIEGO, INC2018-06-29
CLEARVIEW STREP A EXACT II DIPSTICK 30TALERE SAN DIEGO, INC2018-06-01
SOFIA STREP A+ FIAQUIDEL CORPORATION2018-05-08
CONSULT STREP A DIPSTICK 4999 50TALERE SAN DIEGO, INC2017-11-29
BECTON DICKINSON STREP A ANTIGEN DETECTIONBECTON DICKINSON2017-09-27
BECKTON DICKINSON STREP A ANTIGEN DETECTIONBECKTON DICKINSON2017-09-27
CONSULT STREP A DIPSTICK 4999 50TALERE SAN DIEGO, INC2017-07-17
QUICK-VUE DIPSTICK STREP AQUIDEL2015-10-21
QUICKVUE DIPSTICK STREP A TESTQUIDEL CORP.2014-07-25
ICON DS STREP ABECKMAN COULTER, INC.2011-05-18
ICON DS STREP ABECKMAN COULTER, INC.2011-05-18
ICON SC STREP A IMMUNOCHEMICAL TESTBECKMAN COULTER INC.2011-03-29
ICON SC STREP A IMMUNOCHEMICAL TESTBECKMAN COULTER INC.2010-12-30
MEDI-LAB PERFORMANCE STREP A TEST-TWISTBIOSITE INCORPORATED2009-12-16
PSS SELECT STREP A DIPSTICKBIOSITE INC.2009-06-01
ICON DS STREP ABECKMAN COULTER2008-09-16
BIOSTAR OIA STREP BINVERNESS MEDICAL-BIOSTAR INC2008-03-12
BIOSTAR RAPID GBSINVERNESS MEDICAL PROFESSIONAL DIAGNOSISTICS2007-09-19
CARDINALINVERNESS MEDICAL2006-10-09
CLARITY STREP ARAC MEDICALS2006-01-17
ABBOTT SIGNIFY STREP A TEST KITABBOTT LABORATOIRES2005-04-05
OUICKVUE+ RAPID STREP A TESTQUIDEL CORP2003-12-10
ABBOTTABBOTT LABS2003-09-29
DIRECTIGEN 123 GROUP A STREP KITBECTON DICKINSON2001-10-23
QUICKVUE*2001-07-06
QTEST STREP 40 TEST KITBECTON DICKINSON MICROBIOLOGY SYSTEMS1997-06-03
QUIDELQUIDEL1997-04-10
WELCOGEN STREP B TEST LATEX FOR URINE RAPID SCREENSMUREX DIAGNOSTICS, INC.1996-04-23
STREP SELECTBECTON DICKINSON MICROBIOLOGY SYSTEMS1995-05-17
STREPTEX LATEX GRP, AMUREX CORP.1994-03-16

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