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

FDA 510(k) Cleared Antisera, All Groups, Streptococcus Spp. Devices (Product Code GTZ)

105 devices
1–24 of 105
Cleared Nov 30, 2001
BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST
K012521
Binax, Inc.
Microbiology · 116d
Cleared Mar 15, 2001
MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST
K010523
Binax, Inc.
Microbiology · 21d
Cleared Aug 27, 1999
BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI
K991726
Binax, Inc.
Microbiology · 99d
Cleared Mar 03, 1998
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II
K971522
Abbott Laboratories
Microbiology · 312d
Cleared Jul 23, 1997
STREP A OIA MAX
K962060
Biostar, Inc.
Microbiology · 421d
Cleared Dec 16, 1996
STREPTOLEX-STAT
K962296
Unipath , Ltd.
Microbiology · 187d
Cleared Oct 11, 1996
OSOM STREP A TEST
K961423
Wyntek Diagnostics, Inc.
Microbiology · 182d
Cleared Oct 07, 1996
EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT
K962146
Excel Scientific, Inc.
Microbiology · 126d
Cleared Apr 15, 1996
CARDS Q.S. STREP A
K955108
Quidel Corp.
Microbiology · 159d
Cleared Mar 22, 1996
BINAX STREP A TEST
K960712
Binax, Inc.
Microbiology · 30d
Cleared Jan 26, 1996
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC)
K952819
Abbott Laboratories
Microbiology · 220d
Cleared Oct 20, 1995
DIRECTIGEN 1-2-3 GROUP A STREP TEST
K951542
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 200d
Cleared Oct 20, 1995
QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION)
K954257
Quidel Corp.
Microbiology · 85d
Cleared Sep 08, 1995
MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)
K952873
Medix Biotech, Inc.
Microbiology · 94d
Cleared Aug 30, 1995
QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU
K935475
Syntron Bioresearch, Inc.
Microbiology · 653d
Cleared Aug 30, 1995
QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY
K935554
Syntron Bioresearch, Inc.
Microbiology · 651d
Cleared Aug 14, 1995
ABBOTT TEST PACK STREP A TEST
K945571
Abbott Laboratories
Microbiology · 280d
Cleared Jan 27, 1995
PROLEX (STREPTOCCAL GROUPING LATEX KIT)
K934383
Pro-Lab, Inc.
Microbiology · 505d
Cleared Nov 28, 1994
REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST
K942093
Medical Diagnostic Technologies, Inc.
Microbiology · 210d
Cleared Jul 18, 1994
MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010
K932482
Medix Biotech, Inc.
Microbiology · 420d
Cleared Jul 18, 1994
QUICKVUE IN-LINE ONE-STEP STREP A TEST
K934484
Quidel Corp.
Microbiology · 307d
Cleared Dec 02, 1993
STREP A NEGATIVE CONTROL
K924461
Pacific Biotech, Inc.
Microbiology · 456d
Cleared Apr 06, 1993
QUIKPAC STREP A TEST
K924007
Syntron Bioresearch, Inc.
Microbiology · 239d
Cleared Jul 16, 1992
TESTPACK PLUS STREP A
K922345
Abbott Laboratories
Microbiology · 58d

About Product Code GTZ - Regulatory Context