GQN · Class II · 21 CFR 866.3305

FDA Product Code GQN: Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2

Leading manufacturers include Diagnostic Hybrids, Inc., Cordis Corp. and Syva Co..

34
Total
34
Cleared
162d
Avg days
1979
Since

FDA 510(k) Cleared Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 Devices (Product Code GQN)

34 devices
1–24 of 34
Cleared Oct 24, 2007
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000
K070265
Diagnostic Hybrids, Inc.
Microbiology · 268d
Cleared Sep 21, 2007
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000
K063798
Diagnostic Hybrids, Inc.
Microbiology · 273d
Cleared Nov 18, 1997
ELVIS HSV ID/TYPING TEST SYSTEM
K971662
Diagnostic Hybrids, Inc.
Microbiology · 203d
Cleared Sep 05, 1996
ELVIS HSV GOLD
K960578
Diagnostic Hybrids, Inc.
Microbiology · 206d
Cleared May 01, 1995
ELVIS HSV
K941924
Diagnostic Hybrids, Inc.
Microbiology · 376d
Cleared Jun 17, 1991
HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT
K911345
Diagnostic Hybrids, Inc.
Microbiology · 82d
Cleared Dec 05, 1988
MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT.
K884761
Difco Laboratories, Inc.
Microbiology · 21d
Cleared Aug 25, 1988
HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KIT
K873529
Diagnostic Hybrids, Inc.
Microbiology · 359d
Cleared Aug 03, 1988
WELLCOZYME HSV WZO2
K875311
Wellcome Diagnostics
Microbiology · 218d
Cleared May 13, 1988
FITC MURINE MONOCLONAL ANTI-HSV BIVALENT IGG
K880996
Whittaker Bioproducts, Inc.
Microbiology · 66d
Cleared May 13, 1988
FITC MURINE MONOCLONAL ANTI-HERPES TYPE 1 IGG
K881180
Whittaker Bioproducts, Inc.
Microbiology · 66d
Cleared Feb 18, 1988
DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT
K872632
E.I. Dupont DE Nemours & Co., Inc.
Microbiology · 227d
Cleared Feb 18, 1988
MICROTRAK HSV CULTURE IDENTIFICATION TEST
K880436
Syva Co.
Microbiology · 16d
Cleared Feb 04, 1986
ORTHO HSV ANTIGEN ELISA TEST
K854488
Ortho Diagnostic Systems, Inc.
Microbiology · 88d
Cleared Nov 26, 1985
IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF
K842830
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 494d
Cleared May 09, 1985
HERPES SIMPLEX GROUP CF ANTIGEN
K850609
Hillcrest Biologicals
Microbiology · 83d
Cleared Apr 24, 1985
CORDIA HS ANTIBODY TYPING REAGENTS
K843751
Cordis Corp.
Microbiology · 211d
Cleared Jun 19, 1984
MICROTRAKSPECIMAN ID TYPING TEST CONTR
K841191
Syva Co.
Microbiology · 90d
Cleared Nov 28, 1983
CORDIA HS
K832875
Cordis Corp.
Immunology · 94d

About Product Code GQN - Regulatory Context