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 Mar 23, 1992
BBL STREP GROUPING KIT
K920565
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 45d
Cleared Jan 30, 1992
STREP A OIA
K915758
Biosearch Medical Products, Inc.
Microbiology · 38d
Cleared Oct 31, 1991
OIA STREP A
K912889
Biosearch Medical Products, Inc.
Microbiology · 122d
Cleared Aug 07, 1991
GROUP A STREP POSITIVE AND NEGATIVE CONTROLS
K912868
Quidel Corp.
Microbiology · 40d
Cleared Jul 24, 1991
ICON STREP B IMMUNOENZYMETRIC ASSAY
K911417
Hybritech, Inc.
Microbiology · 114d
Cleared Mar 29, 1991
STREPTEX ACID EXTRACTION KIT
K910797
Wellcome Diagnostics
Microbiology · 31d
Cleared Aug 22, 1990
REDITEST STREP A TEST KIT
K903194
Boehringer Mannheim Corp.
Microbiology · 34d
Cleared May 21, 1990
PATHO DX STREP D
K902038
Diagnostic Products Corp.
Immunology · 17d
Cleared May 11, 1990
TESTPACK PLUS STREP A
K901274
Abbott Laboratories
Microbiology · 53d
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 Dec 13, 1989
CARDS O.S.(TM) STREP A
K896221
Pacific Biotech, Inc.
Microbiology · 44d
Cleared Nov 29, 1989
ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION
K895103
Gen-Probe, Inc.
Microbiology · 106d
Cleared Nov 29, 1989
IMMUNOCARD STREP A TEST
K896109
Disease Detection International, Inc.
Microbiology · 37d
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 Apr 12, 1988
V-TREND STREP A TEST
K880483
Texas Immunology, Inc.
Microbiology · 67d
Cleared Mar 03, 1988
TARGET STREP A
K880460
V-Tech, Inc.
Microbiology · 29d
Cleared Nov 20, 1987
BINAX EQUATE STREP B
K872904
Binax, Inc.
Microbiology · 119d
Cleared Sep 30, 1987
SURE-STREP A TEST KIT CATALOG NO. MB-1083
K872346
Medix Biotech, Inc.
Microbiology · 105d