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
49–72 of 105
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 Mar 01, 1988
MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT
K880665
Allelix Diagnostics, Inc.
Microbiology · 12d
Cleared Feb 19, 1988
RAPID COLORIMETRIC DIRECT STREP A TEST
K874761
New Horizons Diagnostics Co.
Microbiology · 92d
Cleared Nov 20, 1987
BINAX EQUATE STREP B
K872904
Binax, Inc.
Microbiology · 119d
Cleared Nov 12, 1987
NOVA STREP A
K873784
Synbiotics Corp.
Microbiology · 56d
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
ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT
K871620
Allelix, Inc.
Microbiology · 51d
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 Jan 13, 1987
REVEAL COLOUR STREP A ZL16
K864206
Wellcome Diagnostics
Microbiology · 78d
Cleared Dec 22, 1986
BINAX STREP A
K863908
Binax, Inc.
Microbiology · 76d
Cleared Nov 26, 1986
CARDS(TM) STREP A CATALOG NO. CR-7545
K863647
Pacific Biotech, Inc.
Microbiology · 69d
Cleared Aug 12, 1986
SEROIDEN STREPTO KIT 'EIKEN'
K861098
Syn-Kit, Inc.
Microbiology · 141d
Cleared May 16, 1986
EZ DETECT, 5 MINUTE STREP-A COLOR TEST
K860923
Self Care Systems, Inc.
Microbiology · 66d
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
MUREX SUDS GROUP A STREP
K860576
Murex Corp.
Microbiology · 45d
Cleared Apr 04, 1986
TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT
K860778
Hybritech, Inc.
Microbiology · 32d