Product Code: GNX FDA class 1 21 CFR 866.3330

Antigens, Cf (Including Cf Control), Influenza Virus A, B, C

Microbiology

The Influenza Virus A, B, and C CF Antigens (Including CF Control) are diagnostic reagents used in complement fixation serological tests to detect antibodies against influenza viruses, supporting the diagnosis and surveillance of seasonal and pandemic influenza. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is GNX, regulated under 21 CFR 866.3330 in the Microbiology specialty.

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FEI Numbers

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Basic Information

Product Code: GNX
Device Class: FDA class 1
Regulation Number: 866.3330
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 4

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 18 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K133411	ALERE BINAXNOW INFLUENZA A & B CARD	Dec 05, 2013	Substantially Equivalent	Alere Scarborough, Inc D/B/A Binax, Inc.
K132352	SAS FLUALERT A & B, SAS INFLUENZA A TEST	Aug 22, 2013	Substantially Equivalent	Sa Scientific , Ltd.
K131804	REMEL XPECT FLU A&B	Jul 12, 2013	Substantially Equivalent	Remel, Inc.
K131606	SOFIA INFLUENZA A+B FIA	Jul 05, 2013	Substantially Equivalent	Quidel Corp.
K131599	QUICK VUE INFLUENZA	Jul 05, 2013	Substantially Equivalent	Quidel Corporation
K131619	QUICKVUE INFLUENZA A+B	Jun 28, 2013	Substantially Equivalent	Quidel Corp.
K123182	OSOM INFLUENZA A&B TEST MODEL 190	Nov 05, 2012	Substantially Equivalent	SEKISUI Diagnostics, LLC
K971494	VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES	Sep 10, 1997	Substantially Equivalent	Zymetx, Inc.
K924006	BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY	Dec 29, 1992	Substantially Equivalent	Baxter Healthcare Corp
K901493	FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B	Jun 27, 1990	Substantially Equivalent	Whittaker Bioproducts, Inc.
K893579	FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A	Jan 16, 1990	Substantially Equivalent	Whittaker Bioproducts, Inc.
K884191	INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION	Nov 22, 1988	Substantially Equivalent	Baxter Diagnostics, Inc.
K872958	IMAGEN INFLUENZA VIRUS A AND B TESTMI	Feb 24, 1988	Substantially Equivalent	Boots-Celltech Diagnostics, Inc.
K871233	ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A	Jun 26, 1987	Substantially Equivalent	Microscan Div. Baxter Healthcare Corp.
K871231	ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B	Jun 26, 1987	Substantially Equivalent	Microscan Div. Baxter Healthcare Corp.
K843660	IN FLUENZA B VIRUS	Sep 26, 1985	Substantially Equivalent	Institute Virion , Ltd.
K843659	INFLUENZA A2 VIRUS	Sep 26, 1985	Substantially Equivalent	Institute Virion , Ltd.
K802931	INFLUENZA A & B S-ANTIGEN & CONTROLS	Jan 12, 1981	Substantially Equivalent	Orion Diagnostica, Inc.