Product Code: GTZ


Products Classified as GTZ

3326Antisera, All Groups, Streptococcus Spp.Streptococcus Spp. Serological Reagents.

Total Product Life Cycle (TPLC) Devices

3326Antisera, All Groups, Streptococcus Spp.Streptococcus Spp. Serological Reagents.

Pre-market Notifications for GTZ

K012521BINAX NOW STREPTOCOCCUS PNEUMONIAE TESTBINAX, INC.
K991726BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONIBINAX, INC.
K962296STREPTOLEX-STATUNIPATH LTD.
K962146EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KITEXCEL SCIENTIFIC, INC.
K962060STREP A OIA MAXBIOSTAR, INC.
K961423OSOM STREP A TESTWYNTEK DIAGNOSTICS, INC.
K960712BINAX STREP A TESTBINAX, INC.
K955108CARDS Q.S. STREP AQUIDEL CORP.
K954257QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION)QUIDEL CORP.
K952819ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC)ABBOTT LABORATORIES
K952873MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)MEDIX BIOTECH, INC.
K951542DIRECTIGEN 1-2-3 GROUP A STREP TESTBD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K945571ABBOTT TEST PACK STREP A TESTABBOTT LABORATORIES
K942093REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TESTMEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
K935554QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAYSYNTRON BIORESEARCH, INC.

Global Unique Device Identification Database

00382902554608ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.
00382902409588ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.
00382902409571ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.
00382902409564ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.
00382902409380ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.
00382902409366ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.
00382902409359ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.
00382902409335ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.
00382902409311ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.
00382902409304ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.
00382902409298ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.
00382902409281ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.
00382902409274ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.
00382902409267ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.
00382902409250ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP.

Maude Adverse Events

ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARDALERE SCARBOROUGH INC.2018-07-18
ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARDALERE SCARBOROUGH INC.2018-07-18
ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARDALERE SCARBOROUGH INC.2018-07-18
ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARDALERE SCARBOROUGH INC.2018-07-18
ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARDALERE SCARBOROUGH INC.2018-07-18
ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARDALERE SCARBOROUGH INC.2018-07-18
ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARDALERE SCARBOROUGH INC.2018-07-18
ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARDALERE SCARBOROUGH INC.2018-07-18
ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARDALERE SCARBOROUGH, INC.2017-11-28
QUIDEL QUICKVUE IN LINE STREP KITQUIDEL2016-09-24
QUIDEL STREP A TESTQUIDEL CORP.2013-01-29
QUICKVUE DIPSTICK STREP A TEST KITQUIDEL CORP.2011-11-07
QUICK IN-LINE STREP A TEST KITQUIDEL CORPORATION2011-09-02
MUREX WELLCOGEN BACTERIAL ANTIGEN KITMUREX DIAGNOSTICS DISTRIBUTED BY REMEL, INC.2001-12-20
SIGNIFY STREP A TESTWYNTEK DIAGNOSTICS, INC.1998-01-13
ICON GROUP B STREP ASSAYHYBRITECH INC.1996-12-04
ICON IMMUNOCONCENTRATION ASSAY FOR GROUP B STREPHYBRITECH INC.1996-10-11
ICON IMMUNOCONCENTRATION ASSAY FOR GROUP B STREPHYBRITECH INCO.1996-10-11

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