Product Code: GQN FDA class 2 21 CFR 866.3305

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

Microbiology

The Antigen, CF (Including CF Control), Herpesvirus Hominis 1,2 is a complement fixation antigen with controls used in serological testing to detect antibodies to herpes simplex virus types 1 and 2. As an FDA Class 2 device, it carries moderate risk and requires 510(k) premarket clearance to establish substantial equivalence before it may be marketed. Regulated under 21 CFR 866.3305 with product code GQN, it is reviewed within the Microbiology specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: GQN
Device Class: FDA class 2
Regulation Number: 866.3305
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 34 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K070265	DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000	Oct 24, 2007	Substantially Equivalent	Diagnostic Hybrids, Inc.
K063798	DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000	Sep 21, 2007	Substantially Equivalent	Diagnostic Hybrids, Inc.
K991880	LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY	Nov 09, 1999	Substantially Equivalent	Light Diagnostics
K971662	ELVIS HSV ID/TYPING TEST SYSTEM	Nov 18, 1997	Substantially Equivalent	Diagnostic Hybrids, Inc.
K971101	HSV-2 ANTIGEN CONTROL SLIDES	Jul 01, 1997	Substantially Equivalent	Viral Antigens, Inc.
K964874	HSV-1 ANTIGEN CONTROL SLIDES	Jul 01, 1997	Substantially Equivalent	Viral Antigens, Inc.
K960578	ELVIS HSV GOLD	Sep 05, 1996	Substantially Equivalent	Diagnostic Hybrids, Inc.
K941924	ELVIS HSV	May 01, 1995	Substantially Equivalent	Diagnostic Hybrids, Inc.
K911345	HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT	Jun 17, 1991	Substantially Equivalent	Diagnostic Hybrids, Inc.
K884761	MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT.	Dec 05, 1988	Substantially Equivalent	Difco Laboratories, Inc.
K883684	HERPES VIRUS CONTROL SLIDES	Sep 28, 1988	Substantially Equivalent	Val Tech Diagnostics, Inc.
K873529	HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KIT	Aug 25, 1988	Substantially Equivalent	Diagnostic Hybrids, Inc.
K880604	COLORGENE HSV DNA HYBRIDIZATION TEST	Aug 03, 1988	Substantially Equivalent	Enzo Biochem, Inc.
K875311	WELLCOZYME HSV WZO2	Aug 03, 1988	Substantially Equivalent	Wellcome Diagnostics
K881180	FITC MURINE MONOCLONAL ANTI-HERPES TYPE 1 IGG	May 13, 1988	Substantially Equivalent	Whittaker Bioproducts, Inc.
K880996	FITC MURINE MONOCLONAL ANTI-HSV BIVALENT IGG	May 13, 1988	Substantially Equivalent	Whittaker Bioproducts, Inc.
K880436	MICROTRAK HSV CULTURE IDENTIFICATION TEST	Feb 18, 1988	Substantially Equivalent	Syva Co.
K872632	DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT	Feb 18, 1988	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K874863	RAMP HERPES SIMPLEX VIRUS (HSV) (CCT)	Feb 16, 1988	Substantially Equivalent	Monoclonal Antibodies, Inc.
K870733	COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA.	May 26, 1987	Substantially Equivalent	Enzo Biochem, Inc.
K870602	IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST	May 08, 1987	Substantially Equivalent	Boots-Celltech Diagnostics, Inc.
K854974	HSV IDR	Mar 07, 1986	Substantially Equivalent	Genus Diagnostics
K854488	ORTHO HSV ANTIGEN ELISA TEST	Feb 04, 1986	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K853307	DIRECT ELISA FOR HERPES SIMPLEX VIRUS	Dec 23, 1985	Substantially Equivalent	Fairleigh Dickinson Laboratories, Inc.
K842830	IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF	Nov 26, 1985	Substantially Equivalent	Bartels Immunodiagnostic Supplies, Inc.
K843658	H. SIMPLEX VIRUS	Sep 26, 1985	Substantially Equivalent	Institute Virion , Ltd.
K850609	HERPES SIMPLEX GROUP CF ANTIGEN	May 09, 1985	Substantially Equivalent	Hillcrest Biologicals
K843751	CORDIA HS ANTIBODY TYPING REAGENTS	Apr 24, 1985	Substantially Equivalent	Cordis Corp.
K841191	MICROTRAKSPECIMAN ID TYPING TEST CONTR	Jun 19, 1984	Substantially Equivalent	Syva Co.
K832541	SIMPLEX-2	Feb 04, 1984	Substantially Equivalent	Gentech Australia
K832875	CORDIA HS	Nov 28, 1983	Substantially Equivalent	Cordis Corp.
K811021	HERPES	Nov 05, 1981	Substantially Equivalent	Immuno-Diagnostic Products, Inc.
K801721	HSV BIO-BEAD TITRATION KIT	Sep 16, 1980	Substantially Equivalent	Litton Bionetics
K791614	HSV BIO-BEAD SCREEN KIT	Nov 13, 1979	Substantially Equivalent	Litton Bionetics