ClearanceBrief
Panels › Microbiology › Product code GQN · Class 2

Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2

Regulation 866.3305

0510(k)s in 12 months (34 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in GQN

Decided510(k)Device and applicantCode
Oct 24, 2007K070265DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000
Diagnostic Hybrids, Inc.
GQN
Sep 21, 2007K063798DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000
Diagnostic Hybrids, Inc.
GQN
Nov 9, 1999K991880LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY
Light Diagnostics
GQN
Nov 18, 1997K971662ELVIS HSV ID/TYPING TEST SYSTEM
Diagnostic Hybrids, Inc.
GQN
Jul 1, 1997K971101HSV-2 ANTIGEN CONTROL SLIDES
Viral Antigens, Inc.
GQN
Jul 1, 1997K964874HSV-1 ANTIGEN CONTROL SLIDES
Viral Antigens, Inc.
GQN
Sep 5, 1996K960578ELVIS HSV GOLD
Diagnostic Hybrids, Inc.
GQN
May 1, 1995K941924ELVIS HSV
Diagnostic Hybrids, Inc.
GQN
Jun 17, 1991K911345HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT
Diagnostic Hybrids, Inc.
GQN
Dec 5, 1988K884761MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT.
Difco Laboratories, Inc.
GQN
Sep 28, 1988K883684HERPES VIRUS CONTROL SLIDES
Val Tech Diagnostics, Inc.
GQN
Aug 25, 1988K873529HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KIT
Diagnostic Hybrids, Inc.
GQN
Aug 3, 1988K880604COLORGENE HSV DNA HYBRIDIZATION TEST
Enzo Biochem, Inc.
GQN
Aug 3, 1988K875311WELLCOZYME HSV WZO2
Wellcome Diagnostics
GQN
May 13, 1988K881180FITC MURINE MONOCLONAL ANTI-HERPES TYPE 1 IGG
Whittaker Bioproducts, Inc.
GQN
May 13, 1988K880996FITC MURINE MONOCLONAL ANTI-HSV BIVALENT IGG
Whittaker Bioproducts, Inc.
GQN
Feb 18, 1988K880436MICROTRAK HSV CULTURE IDENTIFICATION TEST
Syva Co.
GQN
Feb 18, 1988K872632DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT
E.I. Dupont DE Nemours & Co., Inc.
GQN
Feb 16, 1988K874863RAMP HERPES SIMPLEX VIRUS (HSV) (CCT)
Monoclonal Antibodies, Inc.
GQN
May 26, 1987K870733COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA.
Enzo Biochem, Inc.
GQN
May 8, 1987K870602IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST
Boots-Celltech Diagnostics, Inc., GB
GQN
Mar 7, 1986K854974HSV IDR
Genus Diagnostics
GQN
Feb 4, 1986K854488ORTHO HSV ANTIGEN ELISA TEST
Ortho Diagnostic Systems, Inc.
GQN
Dec 23, 1985K853307DIRECT ELISA FOR HERPES SIMPLEX VIRUS
Fairleigh Dickinson Laboratories, Inc.
GQN
Nov 26, 1985K842830IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF
Bartels Immunodiagnostic Supplies, Inc.
GQN
Sep 26, 1985K843658H. SIMPLEX VIRUS
Institute Virion , Ltd.
GQN
May 9, 1985K850609HERPES SIMPLEX GROUP CF ANTIGEN
Hillcrest Biologicals
GQN
Apr 24, 1985K843751CORDIA HS ANTIBODY TYPING REAGENTS
Cordis Corp.
GQN
Jun 19, 1984K841191MICROTRAKSPECIMAN ID TYPING TEST CONTR
Syva Co.
GQN
Feb 4, 1984K832541SIMPLEX-2
Gentech Australia
GQN
Nov 28, 1983K832875CORDIA HS
Cordis Corp.
GQN
Nov 5, 1981K811021HERPES
Immuno-Diagnostic Products, Inc.
GQN
Sep 16, 1980K801721HSV BIO-BEAD TITRATION KIT
Litton Bionetics
GQN
Nov 13, 1979K791614HSV BIO-BEAD SCREEN KIT
Litton Bionetics
GQN

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