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
73–96 of 105
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 Mar 04, 1986
INSTA KIT FOR GROUP A STREP ID
K860247
Mead Johnson & Co.
Microbiology · 39d
Cleared Jan 03, 1986
IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST
K854447
American Micro Scan
Microbiology · 59d
Cleared Dec 05, 1985
ABBOTT STREP A P.S.D.
K852266
Abbott Laboratories
Microbiology · 191d
Cleared Oct 23, 1985
PHADIRECT STREP A TEST
K854150
Pharmacia, Inc.
Microbiology · 12d
Cleared Aug 01, 1985
CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D.
K853073
Marion Laboratories, Inc.
Microbiology · 9d
Cleared Jul 30, 1985
QUIDEL QUEST STREP GROUP A TEST
K852806
Quidel Corp.
Immunology · 27d
Cleared Jul 24, 1985
RAPID DIRECT STREP A LATEX AGGLUTINATION TEST
K852841
Smithkline Diagnostics, Inc.
Microbiology · 19d
Cleared Jul 05, 1985
LATEX AGGLUTINATION TEST
K851132
New Horizons Diagnostics Co.
Microbiology · 106d
Cleared May 29, 1985
BACTIGEN GROUP B STREPTOCOCCUS TEST
K850772
Armkel, LLC
Microbiology · 93d
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 16, 1985
VENTRESCREEN STREP A TEST
K844855
Ventrex Laboratories, Inc.
Microbiology · 33d
Cleared Jan 08, 1985
RESPIRALEX LATEX AGGLUTINATION TEST
K844399
Orion Diagnostica, Inc.
Immunology · 56d
Cleared Jan 04, 1985
DIRECTIGEN GROUP A STREP TEST KIT
K843713
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 105d
Cleared Nov 27, 1984
PHARMACIA STREP A DIRECT SWAB TEST
K844107
Pharmacia, Inc.
Microbiology · 35d
Cleared Oct 30, 1984
DETECT-A-STREP
K843590
Antibodies, Inc.
Microbiology · 48d
Cleared Aug 16, 1984
STREPTEX DIRECT A ZL14
K842827
Wellcome Diagnostics
Immunology · 27d
Cleared Jul 02, 1984
PATHO DX LATEX AGGLUTINATION STREP A
K842383
Diagnostic Products Corp.
Microbiology · 14d
Cleared Apr 04, 1984
DETECT GROUP A STREP TEST
K834582
Difco Laboratories, Inc.
Microbiology · 97d
Cleared Sep 26, 1983
DIRECTIGEN GROUP B STREP TEST KIT-SERUM
K831991
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 97d
Cleared Apr 27, 1983
PHADEBACT STREP F TEST
K830445
Pharmacia, Inc.
Microbiology · 76d