Home / Device Classification / GQN

GQN — Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 Class II

FDA Device Classification

Classification Details

Product Code
GQN
Device Class
Class II
Regulation Number
866.3305
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K070265diagnostic hybridsDIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MOctober 24, 2007
K063798diagnostic hybridsDIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080September 21, 2007
K991880light diagnosticsLIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAYNovember 9, 1999
K971662diagnostic hybridsELVIS HSV ID/TYPING TEST SYSTEMNovember 18, 1997
K964874viral antigensHSV-1 ANTIGEN CONTROL SLIDESJuly 1, 1997
K971101viral antigensHSV-2 ANTIGEN CONTROL SLIDESJuly 1, 1997
K960578diagnostic hybridsELVIS HSV GOLDSeptember 5, 1996
K941924diagnostic hybridsELVIS HSVMay 1, 1995
K911345diagnostic hybridsHSV IN SITU DNA PROBE HYBRIDIZATION TEST KITJune 17, 1991
K884761difco laboratoriesMODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT.December 5, 1988
K883684val tech diagnosticsHERPES VIRUS CONTROL SLIDESSeptember 28, 1988
K873529diagnostic hybridsHYBRIWICK SYSTEM: HERPES DNA PROBE TEST KITAugust 25, 1988
K875311wellcome diagnosticsWELLCOZYME HSV WZO2August 3, 1988
K880604enzo biochemCOLORGENE HSV DNA HYBRIDIZATION TESTAugust 3, 1988
K880996whittaker bioproductsFITC MURINE MONOCLONAL ANTI-HSV BIVALENT IGGMay 13, 1988
K881180whittaker bioproductsFITC MURINE MONOCLONAL ANTI-HERPES TYPE 1 IGGMay 13, 1988
K880436syvaMICROTRAK HSV CULTURE IDENTIFICATION TESTFebruary 18, 1988
K872632e.i. dupont de nemours and coDU PONT HERPCHEK HSV ANTIGEN ELISA TEST KITFebruary 18, 1988
K874863monoclonal antibodiesRAMP HERPES SIMPLEX VIRUS (HSV) (CCT)February 16, 1988
K870733enzo biochemCOLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA.May 26, 1987