GTY · Class I · 21 CFR 866.3740

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

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

44
Total
44
Cleared
101d
Avg days
1981
Since
44 devices
25–44 of 44
Cleared Jul 22, 1992
ABBOTT STREP A CONTROLS
K922490
Abbott Laboratories
Microbiology · 56d
Cleared Jan 28, 1991
SLIDEX STREPTO-KIT
K905020
Vitek Systems, Inc.
Microbiology · 82d
Cleared Jan 18, 1991
KODAK SURECELL(TM) STREP A CONTROL FLUID SET
K904589
Eastman Kodak Company
Microbiology · 101d
Cleared Oct 03, 1990
ICON STREP B IMMUNOENZYMETRIC ASSAY
K902991
Hybritech, Inc.
Microbiology · 86d
Cleared Feb 26, 1987
ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL
K864752
Abbott Laboratories
Microbiology · 83d
Cleared Sep 16, 1986
RESPIRASTICK ENZYME IMMUNOASSAY TEST
K862475
Orion Diagnostica, Inc.
Microbiology · 78d
Cleared Jun 03, 1986
DIRECTATEX STREP A
K861575
Pacific Biotech, Inc.
Microbiology · 36d
Cleared Mar 23, 1984
STREPTOCOCCUS GR. D
K840511
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
STREPTOCOCCUS PNEUMONIAE CONTROL
K840512
Scientific Device Laboratory, Inc.
Microbiology · 46d
Cleared Mar 23, 1984
STREPTOCOCCUS GR. B CONTROL
K840513
Scientific Device Laboratory, Inc.
Microbiology · 46d
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