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
Cleared
Oct 23, 1985
PHADIRECT STREP A TEST
Pharmacia, Inc.
Microbiology
12d
Cleared
Aug 01, 1985
CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D.
Marion Laboratories, Inc.
Microbiology
9d
Cleared
Jul 30, 1985
QUIDEL QUEST STREP GROUP A TEST
Quidel Corp.
Immunology
27d
Cleared
Jul 24, 1985
RAPID DIRECT STREP A LATEX AGGLUTINATION TEST
Smithkline Diagnostics, Inc.
Microbiology
19d
Cleared
May 29, 1985
BACTIGEN GROUP B STREPTOCOCCUS TEST
Armkel, LLC
Microbiology
93d
Cleared
May 02, 1985
PATHO DX LATEX AGGLUTINATION STREP B KIT
Diagnostic Products Corp.
Microbiology
126d
Cleared
Apr 08, 1985
CONFIRM IMMUNOASSAY FOR DETECTTION STREP-PYOGENES
Abbott Laboratories
Microbiology
76d
Cleared
Apr 08, 1985
STREP A QUICK
Abbott Laboratories
Microbiology
38d
Cleared
Jan 16, 1985
VENTRESCREEN STREP A TEST
Ventrex Laboratories, Inc.
Microbiology
33d
Cleared
Jan 04, 1985
DIRECTIGEN GROUP A STREP TEST KIT
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology
105d
Cleared
Nov 27, 1984
PHARMACIA STREP A DIRECT SWAB TEST
Pharmacia, Inc.
Microbiology
35d
Cleared
Jul 02, 1984
PATHO DX LATEX AGGLUTINATION STREP A
Diagnostic Products Corp.
Microbiology
14d
Cleared
Apr 04, 1984
DETECT GROUP A STREP TEST
Difco Laboratories, Inc.
Microbiology
97d
Cleared
Sep 26, 1983
DIRECTIGEN GROUP B STREP TEST KIT-SERUM
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology
97d
Cleared
Apr 27, 1983
PHADEBACT STREP F TEST
Pharmacia, Inc.
Microbiology
76d
Cleared
Mar 01, 1983
ABBOTT LABORATORIES STREP A EIA
Abbott Laboratories
Chemistry
88d
Cleared
May 13, 1982
MERITECASTREP (TM)
Meridian Diagnostics, Inc.
Microbiology
23d
Cleared
Jun 20, 1980
STREPTO-SEC TM
Organon, Inc.
Microbiology
40d
Cleared
Apr 29, 1980
PHADEBACT STREP D TEST
Pharmacia, Inc.
Microbiology
96d