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
97–105 of 105
Cleared Mar 01, 1983
ABBOTT LABORATORIES STREP A EIA
K823569
Abbott Laboratories
Chemistry · 88d
Cleared May 13, 1982
MERITECASTREP (TM)
K821100
Meridian Diagnostics, Inc.
Microbiology · 23d
Cleared Feb 18, 1982
WELLCOGEN GROUP B
K820069
Burroughs Wellcome Co.
Microbiology · 37d
Cleared Oct 10, 1980
SERO STREP KIT
K801775
Sacks Farms Biological Products
Microbiology · 74d
Cleared Jun 20, 1980
STREPTO-SEC TM
K801159
Organon, Inc.
Microbiology · 40d
Cleared Apr 29, 1980
PHADEBACT STREP D TEST
K800159
Pharmacia, Inc.
Microbiology · 96d
Cleared May 01, 1979
SERO-STAT STREPTOCOCCUS TEST
K790492
Scott Laboratories, Inc.
Microbiology · 49d
Cleared Oct 17, 1978
STREP-TEX
K781607
Burroughs Wellcome Co.
Immunology · 29d
Cleared Aug 03, 1976
TEST, ANTIBODIES FOR GRP A, LATEX SLIDE
K760033
Gamma Biologicals, Inc.
Microbiology · 50d