GQL · Class II · 21 CFR 866.3305

FDA Product Code GQL: Antisera, Fluorescent, Herpesvirus Hominis 1,2

Leading manufacturers include Zeus Scientific, Inc., Immulok, Inc. and Syva Co..

37
Total
37
Cleared
123d
Avg days
1977
Since
37 devices
25–37 of 37
Cleared Jul 18, 1983
HSV IGM TEST
K830865
Gull Laboratories, Inc.
Microbiology · 122d
Cleared Jul 07, 1983
INDIRECT FLUORO-KIT HSV
K830623
Clinical Sciences, Inc.
Microbiology · 129d
Cleared Jun 30, 1983
HERPES SIMPLEX VIRUS TYPING REAGENTS
K830971
Immulok, Inc.
Microbiology · 94d
Cleared Jun 22, 1983
MICRO TRAK HSV1 & 2 CULTURE CONFIRMATION
K830953
Syva Co.
Microbiology · 89d
Cleared Nov 29, 1982
FLUOROSET IMMUNOFLUORESCENT ANTIBODY
K822785
Immulok, Inc.
Microbiology · 76d
Cleared Jun 25, 1982
HISTOSET IMMUNOPEROFIDASE TISSUE
K821411
Immulok, Inc.
Pathology · 44d
Cleared Jun 25, 1982
IMMULOK CULTURESET
K821567
Immulok, Inc.
Microbiology · 31d
Cleared Sep 01, 1981
HERPES VIRUS HOMINIS ANTIBODY TEST SYS.
K812085
Zeus Scientific, Inc.
Microbiology · 41d
Cleared Feb 09, 1981
DIRECT FLUORESCENT ANTIBODY KIT/HERPES
K802590
Bartels & Stout, Inc.
Microbiology · 117d
Cleared Jan 28, 1981
HERPES SIMPLEX VIRUS SEROLOGICAL REAGENT
K803132
Microbiological Research Corp.
Microbiology · 47d
Cleared Mar 03, 1980
FIAX TEST KIT FOR HERPES SIMPLEX VIRUS
K792559
Intl. Diagnostic Technology
Chemistry · 83d
Cleared Dec 14, 1977
HERPES I.D. TM TEST
K771445
Hyland Therapeutic Div., Travenol Laboratories
Microbiology · 135d
Cleared Jul 11, 1977
HSV TEST
K771063
Gull Laboratories, Inc.
Microbiology · 28d