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
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 08, 1985
RESPIRALEX LATEX AGGLUTINATION TEST
Orion Diagnostica, Inc.
Immunology
56d
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
Aug 16, 1984
STREPTEX DIRECT A ZL14
Wellcome Diagnostics
Immunology
27d
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
Feb 18, 1982
WELLCOGEN GROUP B
Burroughs Wellcome Co.
Microbiology
37d
Cleared
Jun 20, 1980
STREPTO-SEC TM
Organon, Inc.
Microbiology
40d
Cleared
Apr 29, 1980
PHADEBACT STREP D TEST
Pharmacia, Inc.
Microbiology
96d
Cleared
Oct 17, 1978
STREP-TEX
Burroughs Wellcome Co.
Immunology
29d
Cleared
Aug 03, 1976
TEST, ANTIBODIES FOR GRP A, LATEX SLIDE
Gamma Biologicals, Inc.
Microbiology
50d