ClearanceBrief
Panels › Microbiology › Product code GQL · Class 2

Antisera, Fluorescent, Herpesvirus Hominis 1,2

Regulation 866.3305

0510(k)s in 12 months (37 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in GQL

Company510(k)sRecalls
Zeus Scientific, Inc.50
Immulok, Inc.40
Syva Co.40
Ortho Diagnostic Systems, Inc.30
Baxter Healthcare Corp20
Gull Laboratories, Inc.20
Bartels & Stout, Inc.10
California Integrated Diagnostics, Inc.10
Clinical Sciences, Inc.10
Diagnon Corp.10
Decided510(k)Device and applicantCode
Aug 28, 2009K091753ELVIS HSV ID AND D3 TYPING TEST SYSTEM
Diagnostic Hybrids, Inc.
GQL
Apr 1, 2009K081527LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT
Millipore Corporation
GQL
May 26, 1999K984135THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
Zeus Scientific, Inc.
GQL
May 26, 1999K984120THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH
Zeus Scientific, Inc.
GQL
Nov 7, 1991K905608INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1
Stellar Bio Systems, Inc.
GQL
Feb 1, 1991K904095HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING
California Integrated Diagnostics, Inc.
GQL
Dec 13, 1990K904167PATHODX HERPES TYPING
Diagnostic Products Corp.
GQL
Jul 31, 1990K902662BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST
Baxter Healthcare Corp
GQL
Jul 31, 1990K902661BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2
Baxter Healthcare Corp
GQL
Jun 20, 1989K891782HSV-2 ELISA TEST SYSTEM
Zeus Scientific, Inc.
GQL
Jun 20, 1989K891162HSV-1 ELISA TEST SYSTEM
Zeus Scientific, Inc.
GQL
Jun 6, 1989K891382ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES
Ortho Diagnostic Systems, Inc.
GQL
Jun 4, 1987K870814HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2
Microscan Div. Baxter Healthcare Corp.
GQL
Oct 10, 1985K851635DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST
Diagnon Corp.
GQL
Sep 12, 1985K852360ORTHO DNA PROBE HSV CONFIRMATION TEST
Ortho Diagnostic Systems, Inc.
GQL
Jul 30, 1985K852125PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP
Kallestad Laboratories, Inc.
GQL
Jul 12, 1985K851372CELLMATICS HERPES SIMPLEX VIRUS DETECT-SYS
Difco Laboratories, Inc.
GQL
Mar 13, 1985K841943GIBCO HERPES ID KIT
Gibco Laboratories Life Technologies, Inc.
GQL
Mar 11, 1985K850739AMENDMENT TO LABELING MICROTRAK HSV 1/HSV 2 DIRECT
Syva Co.
GQL
Jan 29, 1985K842216CULTURESET HSV ISOLATION & ID SYS
Ortho Diagnostic Systems, Inc.
GQL
Jan 18, 1985K841190MICROTRAK HSV 1 & 2 DIRECT SPECIMAN
Syva Co.
GQL
Oct 30, 1984K841680SCOTT SELECTICULT-HSV ISOLATION &
Scott Laboratories, Inc.
GQL
May 7, 1984K840494MICROTRAK HSV 1 & 2 CULTURE
Syva Co.
GQL
Sep 20, 1983K831504HERPES IDENT. & TYPING TEST HITT
Electro-Nucleonics Laboratories, Inc.
GQL
Jul 18, 1983K830865HSV IGM TEST
Gull Laboratories, Inc.
GQL
Jul 7, 1983K830623INDIRECT FLUORO-KIT HSV
Clinical Sciences, Inc.
GQL
Jun 30, 1983K830971HERPES SIMPLEX VIRUS TYPING REAGENTS
Immulok, Inc.
GQL
Jun 22, 1983K830953MICRO TRAK HSV1 & 2 CULTURE CONFIRMATION
Syva Co.
GQL
Nov 29, 1982K822785FLUOROSET IMMUNOFLUORESCENT ANTIBODY
Immulok, Inc.
GQL
Jun 25, 1982K821567IMMULOK CULTURESET
Immulok, Inc.
GQL
Jun 25, 1982K821411HISTOSET IMMUNOPEROFIDASE TISSUE
Immulok, Inc.
GQL
Sep 1, 1981K812085HERPES VIRUS HOMINIS ANTIBODY TEST SYS.
Zeus Scientific, Inc.
GQL
Feb 9, 1981K802590DIRECT FLUORESCENT ANTIBODY KIT/HERPES
Bartels & Stout, Inc.
GQL
Jan 28, 1981K803132HERPES SIMPLEX VIRUS SEROLOGICAL REAGENT
Microbiological Research Corp.
GQL
Mar 3, 1980K792559FIAX TEST KIT FOR HERPES SIMPLEX VIRUS
Intl. Diagnostic Technology
GQL
Dec 14, 1977K771445HERPES I.D. TM TEST
Hyland Therapeutic Div., Travenol Laboratories
GQL
Jul 11, 1977K771063HSV TEST
Gull Laboratories, Inc.
GQL

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