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 10, 1995
QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & NEGATIVE SWAB SPECIMENS)
K945080
Quidel Corp.
Microbiology · 116d
Cleared Jul 06, 1994
STREP B OIA
K936112
Biostar, Inc.
Microbiology · 195d
Cleared Apr 21, 1994
QTEST(R) STREP
K935667
Becton Dickinson Advanced Diagnostics
Microbiology · 146d
Cleared Aug 20, 1992
BIOSTARS STREP A OIA -- MODIFICATION
K922765
Biosearch Medical Products, Inc.
Microbiology · 79d
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 Oct 25, 1988
STREPSLIDE
K882811
Ncs Diagnostics, Inc.
Microbiology · 110d
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 25, 1986
HYGEIA RAPID STREP A TEST
K862133
Hygeia Sciences
Microbiology · 21d
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