Product Code: GQO FDA class 2 21 CFR 866.3305

Antisera, Cf, Herpesvirus Hominis 1,2

Microbiology

The Antisera, CF, Herpesvirus Hominis 1,2 is a complement fixation antiserum used in clinical microbiology laboratories to detect antibodies to herpes simplex virus types 1 and 2. It is an FDA Class 2 device, presenting moderate risk and requiring 510(k) premarket notification before marketing. The product code is GQO, regulated under 21 CFR 866.3305 within the Microbiology specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: GQO
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

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 16 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K883282	VIRGO HSV-1 IGG ELISA	Mar 10, 1989	Substantially Equivalent	Electro-Nucleonics, Inc.
K883281	VIRGO HSV-2 IGG ELISA	Mar 10, 1989	Substantially Equivalent	Electro-Nucleonics, Inc.
K881261	BION HSV1-G OR HSV2-G TEST SYSTEM	Jun 07, 1988	Substantially Equivalent	Bion Ent., Ltd.
K875366	THE DDI SERODOT HERPES IGG TEST KIT	May 23, 1988	Substantially Equivalent	Disease Detection International, Inc.
K871426	VIROGEN HSV ANTIBODY TEST	Oct 15, 1987	Substantially Equivalent	Armkel, LLC
K861120	THE GOLDEN QUAD TEST (HSV)	Feb 02, 1987	Substantially Equivalent	Microbiological Research Corp.
K854712	VISIBLE-HERPES TM TEST SYSTEM	May 20, 1986	Substantially Equivalent	Isolab, Inc.
K852782	HSVI - IGG ELISA-KIT	Jan 21, 1986	Substantially Equivalent	Clinical Sciences, Inc.
K852781	HSV2 - IGG ELISA-KIT	Jan 21, 1986	Substantially Equivalent	Clinical Sciences, Inc.
K842663	ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2	Dec 06, 1985	Substantially Equivalent	Amico Lab, Inc.
K842531	AMIZYME-HSV TYPES 1 & 2 TEST KITS	Dec 06, 1985	Substantially Equivalent	Amico Lab, Inc.
K852931	HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT	Nov 12, 1985	Substantially Equivalent	Microbix Biosystems, Inc.
K841245	ENZYGNOST ANTIHERPES SIMPLEX VIRUS	Nov 05, 1985	Substantially Equivalent	Behring Diagnostics, Inc.
K852928	VIROGEN HERPES SLIDE TEST	Oct 17, 1985	Substantially Equivalent	Armkel, LLC
K842887	HERPES VIRUS AGGLUTINATION TEST	Feb 26, 1985	Substantially Equivalent	Scientific Research
K791058	ANTIBODY TO HERPESVIRUS HOMINIS	Sep 07, 1979	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.