Product Code: GQH FDA class 2 21 CFR 866.3175

Antigen, Cf (Including Cf Control), Cytomegalovirus

Microbiology

The Antigen, CF (Including CF Control), Cytomegalovirus is a complement fixation antigen with associated controls used in clinical laboratory testing to detect CMV antibodies in patient specimens. It is an FDA Class 2 device, indicating moderate risk; manufacturers must submit a 510(k) premarket notification to demonstrate substantial equivalence before marketing. Regulated under 21 CFR 866.3175 with product code GQH, it is reviewed within the Microbiology specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

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Basic Information

Product Code: GQH
Device Class: FDA class 2
Regulation Number: 866.3175
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

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 19 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K982311	BARTELS CINAKIT CMV ANTIGENEMIA	Dec 14, 1998	Substantially Equivalent	Intracel Corp.
K964875	CMV ANTIGEN CONTROL SLIDES	Mar 18, 1997	Substantially Equivalent	Viral Antigens, Inc.
K935809	CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY	May 05, 1994	Substantially Equivalent	Light Diagnostics
K882835	INDIRECT FLUORESCENT ASSAY FOR (HCMV)	Dec 05, 1988	Substantially Equivalent	Stellar Bio Systems, Inc.
K882024	FITC MURINE MONOCLONAL ANTI-CMV IGG	Aug 03, 1988	Substantially Equivalent	Whittaker Bioproducts, Inc.
K881932	ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT	Aug 01, 1988	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K880679	BION CMV-G TEST SYSTEM	Jun 03, 1988	Substantially Equivalent	Bion Ent., Ltd.
K880290	MICROTRAK CMV CULTURE CONFIRMATION TEST	Apr 19, 1988	Substantially Equivalent	Syva Co.
K872576	COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION	Dec 04, 1987	Substantially Equivalent	Enzo Biochem, Inc.
K873114	CYTOMEGALOVIRUS CONTROL SLIDES	Sep 25, 1987	Substantially Equivalent	Medical Diagnostic Technologies, Inc.
K864565	MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT	Feb 19, 1987	Substantially Equivalent	Serono Diagnostics, Inc.
K843657	CYTOMEGALOVIRUS	Sep 26, 1985	Substantially Equivalent	Institute Virion , Ltd.
K833089	CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II	May 02, 1984	Substantially Equivalent	Clinical Sciences, Inc.
K811671	CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM	Sep 16, 1981	Substantially Equivalent	Zeus Scientific, Inc.
K802930	CYTOMEGALO VIRUS & CONTROLS	Jan 09, 1981	Substantially Equivalent	Orion Diagnostica, Inc.
K801963	CMV TEST KIT	Oct 23, 1980	Substantially Equivalent	Immuno-Diagnostic Products, Inc.
K801722	CMV BIO-BEAD TITRATION KIT	Sep 16, 1980	Substantially Equivalent	Litton Bionetics
K791948	FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS	Nov 16, 1979	Substantially Equivalent	Intl. Diagnostic Technology
K791612	CMV BIO-BEAD SCREEN KIT	Nov 13, 1979	Substantially Equivalent	Litton Bionetics