Product Code: GTZ

Products Classified as GTZ

3326

Antisera, All Groups, Streptococcus Spp.

Streptococcus Spp. Serological Reagents.

Total Product Life Cycle (TPLC) Devices

3326

Antisera, All Groups, Streptococcus Spp.

Streptococcus Spp. Serological Reagents.

Pre-market Notifications for GTZ

K012521	BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST	BINAX, INC.
K991726	BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI	BINAX, INC.
K962296	STREPTOLEX-STAT	UNIPATH LTD.
K962146	EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT	EXCEL SCIENTIFIC, INC.
K962060	STREP A OIA MAX	BIOSTAR, INC.
K961423	OSOM STREP A TEST	WYNTEK DIAGNOSTICS, INC.
K960712	BINAX STREP A TEST	BINAX, INC.
K955108	CARDS Q.S. STREP A	QUIDEL CORP.
K954257	QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION)	QUIDEL CORP.
K952819	ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC)	ABBOTT LABORATORIES
K952873	MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)	MEDIX BIOTECH, INC.
K951542	DIRECTIGEN 1-2-3 GROUP A STREP TEST	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K945571	ABBOTT TEST PACK STREP A TEST	ABBOTT LABORATORIES
K942093	REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST	MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
K935554	QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY	SYNTRON BIORESEARCH, INC.

Global Unique Device Identification Database

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

Maude Adverse Events

ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD	ALERE SCARBOROUGH INC.	2018-07-18
ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD	ALERE SCARBOROUGH INC.	2018-07-18
ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD	ALERE SCARBOROUGH INC.	2018-07-18
ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD	ALERE SCARBOROUGH INC.	2018-07-18
ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD	ALERE SCARBOROUGH INC.	2018-07-18
ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD	ALERE SCARBOROUGH INC.	2018-07-18
ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD	ALERE SCARBOROUGH INC.	2018-07-18
ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD	ALERE SCARBOROUGH INC.	2018-07-18
ALERE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD	ALERE SCARBOROUGH, INC.	2017-11-28
QUIDEL QUICKVUE IN LINE STREP KIT	QUIDEL	2016-09-24
QUIDEL STREP A TEST	QUIDEL CORP.	2013-01-29
QUICKVUE DIPSTICK STREP A TEST KIT	QUIDEL CORP.	2011-11-07
QUICK IN-LINE STREP A TEST KIT	QUIDEL CORPORATION	2011-09-02
MUREX WELLCOGEN BACTERIAL ANTIGEN KIT	MUREX DIAGNOSTICS DISTRIBUTED BY REMEL, INC.	2001-12-20
SIGNIFY STREP A TEST	WYNTEK DIAGNOSTICS, INC.	1998-01-13
ICON GROUP B STREP ASSAY	HYBRITECH INC.	1996-12-04
ICON IMMUNOCONCENTRATION ASSAY FOR GROUP B STREP	HYBRITECH INC.	1996-10-11
ICON IMMUNOCONCENTRATION ASSAY FOR GROUP B STREP	HYBRITECH INCO.	1996-10-11