GTZ · Class I · 21 CFR 866.3740

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

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

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 Mar 03, 1998
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II
K971522
Abbott Laboratories
Microbiology · 312d
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 Aug 14, 1995
ABBOTT TEST PACK STREP A TEST
K945571
Abbott Laboratories
Microbiology · 280d
Cleared Jul 16, 1992
TESTPACK PLUS STREP A
K922345
Abbott Laboratories
Microbiology · 58d
Cleared Mar 23, 1992
BBL STREP GROUPING KIT
K920565
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 45d
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 Apr 21, 1988
KODAK SURECELL STREP A TEST KIT
K881457
Eastman Kodak Company
Microbiology · 15d
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 Mar 10, 1987
DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST
K870155
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 56d
Cleared May 13, 1986
DIRECTIGEN COMBO MENINGITIS TEST
K860768
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 71d
Cleared Dec 05, 1985
ABBOTT STREP A P.S.D.
K852266
Abbott Laboratories
Microbiology · 191d
Cleared May 02, 1985
PATHO DX LATEX AGGLUTINATION STREP B KIT
K845022
Diagnostic Products Corp.
Microbiology · 126d
Cleared Apr 08, 1985
CONFIRM IMMUNOASSAY FOR DETECTTION STREP-PYOGENES
K850256
Abbott Laboratories
Microbiology · 76d
Cleared Apr 08, 1985
STREP A QUICK
K850831
Abbott Laboratories
Microbiology · 38d
Cleared Jan 04, 1985
DIRECTIGEN GROUP A STREP TEST KIT
K843713
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 105d
Cleared Jul 02, 1984
PATHO DX LATEX AGGLUTINATION STREP A
K842383
Diagnostic Products Corp.
Microbiology · 14d
Cleared Sep 26, 1983
DIRECTIGEN GROUP B STREP TEST KIT-SERUM
K831991
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 97d
Cleared Mar 01, 1983
ABBOTT LABORATORIES STREP A EIA
K823569
Abbott Laboratories
Chemistry · 88d

About Product Code GTZ - Regulatory Context