GTZ · Class I · 21 CFR 866.3740

FDA Product Code GTZ: Antisera, All Groups, Streptococcus Spp.

Leading manufacturers include Abbott Laboratories, Quidel Corp. and Bd Becton Dickinson Vacutainer Systems Preanalytic.

105
Total
105
Cleared
106d
Avg days
1976
Since
105 devices
25–48 of 105
Cleared Feb 16, 1990
QUIDEL GROUP B STREP TEST
K896265
Quidel Corp.
Microbiology · 108d
Cleared Jan 22, 1990
VENTRESIGN STREP A TEST
K897083
Ventrex Laboratories, Inc.
Microbiology · 33d
Cleared Nov 29, 1989
ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION
K895103
Gen-Probe, Inc.
Microbiology · 106d
Cleared Nov 14, 1989
ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA.
K894711
Gen-Probe, Inc.
Microbiology · 111d
Cleared Aug 15, 1989
LEECO VIS-DISK STREP-A (EIA)
K894122
Leeco Diagnostics, Inc.
Microbiology · 64d
Cleared Jun 23, 1989
CLEARVIEW STREP A
K893422
Unipath , Ltd.
Microbiology · 52d
Cleared Feb 07, 1989
BACTIGEN(R) GROUP B STREPTOCOCCUS TEST
K885003
Armkel, LLC
Microbiology · 68d
Cleared Oct 12, 1988
QUIDEL GROUP A STREP TEST
K883999
Quidel Corp.
Microbiology · 23d
Cleared Apr 21, 1988
KODAK SURECELL STREP A TEST KIT
K881457
Eastman Kodak Company
Microbiology · 15d
Cleared Sep 30, 1987
SURE-STREP A TEST KIT CATALOG NO. MB-1083
K872346
Medix Biotech, Inc.
Microbiology · 105d
Cleared Sep 29, 1987
QTEST STREP
K872961
Quidel Corp.
Microbiology · 62d
Cleared Aug 27, 1987
BACTIGEN GROUP B STREPTOCOCCUS-CS TEST
K872114
Armkel, LLC
Microbiology · 87d
Cleared Aug 24, 1987
DIRECTIGEN 1-2-3(TM) GROUP A STREP TEST
K872493
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 62d
Cleared Jun 17, 1987
PATHO DX LATEX AGGLUTINATION STREP GROUPING KIT
K871831
Diagnostic Products Corp.
Microbiology · 37d
Cleared Apr 28, 1987
BACTO(R) STREP GROUP KIT
K870854
Difco Laboratories, Inc.
Microbiology · 56d
Cleared Mar 10, 1987
DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST
K870155
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 56d
Cleared Feb 03, 1987
LEECO VIS-CUBE STREP A (EIA)
K864170
Leeco Diagnostics, Inc.
Microbiology · 102d
Cleared Aug 12, 1986
SEROIDEN STREPTO KIT 'EIKEN'
K861098
Syn-Kit, Inc.
Microbiology · 141d
Cleared May 13, 1986
DIRECTIGEN COMBO MENINGITIS TEST
K860768
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 71d
Cleared May 13, 1986
LEECO-SCREEN, STREP A (EIA)
K860947
Leeco Diagnostics, Inc.
Microbiology · 62d
Cleared Apr 04, 1986
TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT
K860778
Hybritech, Inc.
Microbiology · 32d
Cleared Mar 18, 1986
DIFCO STREP A LATEX TEST
K854978
Difco Laboratories, Inc.
Microbiology · 96d
Cleared Mar 11, 1986
OXOID STREPTOCOCAL GROUPING KIT
K854929
Oxoid U.S.A., Inc.
Microbiology · 91d
Cleared Dec 05, 1985
ABBOTT STREP A P.S.D.
K852266
Abbott Laboratories
Microbiology · 191d