GTY · Class I · 21 CFR 866.3740

FDA Product Code GTY: Antigens, All Groups, Streptococcus Spp.

Leading manufacturers include Princeton BioMeditech Corp., Sa Scientific, Inc. and Quidel Corporation.

44
Total
44
Cleared
101d
Avg days
1981
Since
44 devices
25–44 of 44
Cleared Feb 26, 1987
ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL
K864752
Abbott Laboratories
Microbiology · 83d
Cleared Mar 02, 1984
PHADEBACT CSF POSITIVE CONTROLS
K840048
Pharmacia, Inc.
Immunology · 56d
Cleared Sep 01, 1983
PHADEBACT STREP POSITIVE CONTROLS
K832248
Pharmacia, Inc.
Hematology · 52d
Cleared Aug 11, 1983
MERITEC-STREP GROUP A BETA-HEMOLYTIC
K831599
Meridian Diagnostics, Inc.
Microbiology · 86d
Cleared Dec 30, 1981
BBL DIRECTIGEN TEST KIT
K812808
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 85d