Product Code: GQL FDA class 2 21 CFR 866.3305

Antisera, Fluorescent, Herpesvirus Hominis 1,2

Microbiology

The Antisera, Fluorescent, Herpesvirus Hominis 1,2 is a fluorescent-labeled antiserum used in laboratory tests to identify herpes simplex virus types 1 and 2 (HSV-1 and HSV-2) in clinical specimens via immunofluorescence. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is GQL, regulated under 21 CFR 866.3305 in the Microbiology specialty. No special flags apply to this device.

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FEI Numbers

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Basic Information

Product Code: GQL
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 37 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K091753	ELVIS HSV ID AND D3 TYPING TEST SYSTEM	Aug 28, 2009	Substantially Equivalent	Diagnostic Hybrids, Inc.
K081527	LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT	Apr 01, 2009	Substantially Equivalent	Millipore Corporation
K984135	THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR	May 26, 1999	Substantially Equivalent	Zeus Scientific, Inc.
K984120	THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH	May 26, 1999	Substantially Equivalent	Zeus Scientific, Inc.
K905608	INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1	Nov 07, 1991	Substantially Equivalent	Stellar Bio Systems, Inc.
K904095	HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING	Feb 01, 1991	Substantially Equivalent	California Integrated Diagnostics, Inc.
K904167	PATHODX HERPES TYPING	Dec 13, 1990	Substantially Equivalent	Diagnostic Products Corp.
K902662	BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST	Jul 31, 1990	Substantially Equivalent	Baxter Healthcare Corp
K902661	BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2	Jul 31, 1990	Substantially Equivalent	Baxter Healthcare Corp
K891782	HSV-2 ELISA TEST SYSTEM	Jun 20, 1989	Substantially Equivalent	Zeus Scientific, Inc.
K891162	HSV-1 ELISA TEST SYSTEM	Jun 20, 1989	Substantially Equivalent	Zeus Scientific, Inc.
K891382	ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES	Jun 06, 1989	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K870814	HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2	Jun 04, 1987	Substantially Equivalent	Microscan Div. Baxter Healthcare Corp.
K851635	DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST	Oct 10, 1985	Substantially Equivalent	Diagnon Corp.
K852360	ORTHO DNA PROBE HSV CONFIRMATION TEST	Sep 12, 1985	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K852125	PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP	Jul 30, 1985	Substantially Equivalent	Kallestad Laboratories, Inc.
K851372	CELLMATICS HERPES SIMPLEX VIRUS DETECT-SYS	Jul 12, 1985	Substantially Equivalent	Difco Laboratories, Inc.
K841943	GIBCO HERPES ID KIT	Mar 13, 1985	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K850739	AMENDMENT TO LABELING MICROTRAK HSV 1/HSV 2 DIRECT	Mar 11, 1985	Substantially Equivalent	Syva Co.
K842216	CULTURESET HSV ISOLATION & ID SYS	Jan 29, 1985	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K841190	MICROTRAK HSV 1 & 2 DIRECT SPECIMAN	Jan 18, 1985	Substantially Equivalent	Syva Co.
K841680	SCOTT SELECTICULT-HSV ISOLATION &	Oct 30, 1984	Substantially Equivalent	Scott Laboratories, Inc.
K840494	MICROTRAK HSV 1 & 2 CULTURE	May 07, 1984	Substantially Equivalent	Syva Co.
K831504	HERPES IDENT. & TYPING TEST HITT	Sep 20, 1983	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.
K830865	HSV IGM TEST	Jul 18, 1983	Substantially Equivalent	Gull Laboratories, Inc.
K830623	INDIRECT FLUORO-KIT HSV	Jul 07, 1983	Substantially Equivalent	Clinical Sciences, Inc.
K830971	HERPES SIMPLEX VIRUS TYPING REAGENTS	Jun 30, 1983	Substantially Equivalent	Immulok, Inc.
K830953	MICRO TRAK HSV1 & 2 CULTURE CONFIRMATION	Jun 22, 1983	Substantially Equivalent	Syva Co.
K822785	FLUOROSET IMMUNOFLUORESCENT ANTIBODY	Nov 29, 1982	Substantially Equivalent	Immulok, Inc.
K821567	IMMULOK CULTURESET	Jun 25, 1982	Substantially Equivalent	Immulok, Inc.
K821411	HISTOSET IMMUNOPEROFIDASE TISSUE	Jun 25, 1982	Substantially Equivalent	Immulok, Inc.
K812085	HERPES VIRUS HOMINIS ANTIBODY TEST SYS.	Sep 01, 1981	Substantially Equivalent	Zeus Scientific, Inc.
K802590	DIRECT FLUORESCENT ANTIBODY KIT/HERPES	Feb 09, 1981	Substantially Equivalent	Bartels & Stout, Inc.
K803132	HERPES SIMPLEX VIRUS SEROLOGICAL REAGENT	Jan 28, 1981	Substantially Equivalent	Microbiological Research Corp.
K792559	FIAX TEST KIT FOR HERPES SIMPLEX VIRUS	Mar 03, 1980	Substantially Equivalent	Intl. Diagnostic Technology
K771445	HERPES I.D. TM TEST	Dec 14, 1977	Substantially Equivalent	Hyland Therapeutic Div., Travenol Laboratories
K771063	HSV TEST	Jul 11, 1977	Substantially Equivalent	Gull Laboratories, Inc.