FDA Product Code GNX

Product Code: GNX

Products Classified as GNX

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

Influenza Virus Serological Reagents.

Total Product Life Cycle (TPLC) Devices

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

Influenza Virus Serological Reagents.

Pre-market Notifications for GNX

K133411	ALERE BINAXNOW INFLUENZA A & B CARD	ALERE SCARBOROUGH, INC D/B/A BINAX, INC.
K132352	SAS FLUALERT A & B, SAS INFLUENZA A TEST	SA SCIENTIFIC LTD.
K131804	REMEL XPECT FLU A&B	REMEL, INC.
K131619	QUICKVUE INFLUENZA A+B	QUIDEL CORP.
K131599	QUICK VUE INFLUENZA	QUIDEL CORPORATION
K131606	SOFIA INFLUENZA A+B FIA	QUIDEL CORP.
K123182	OSOM INFLUENZA A&B TEST MODEL 190	SEKISUI DIAGNOSTICS, LLC
K971494	VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES	ZYMETX, INC.
K901493	FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B	WHITTAKER BIOPRODUCTS, INC.
K893579	FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A	WHITTAKER BIOPRODUCTS, INC.
K884191	INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION	BAXTER DIAGNOSTICS, INC.
K872958	IMAGEN INFLUENZA VIRUS A AND B TESTMI	BOOTS-CELLTECH DIAGNOSTICS, INC.
K871233	ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A	MICROSCAN DIV. BAXTER HEALTHCARE CORP.
K871231	ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B	MICROSCAN DIV. BAXTER HEALTHCARE CORP.
K843660	IN FLUENZA B VIRUS	INSTITUTE VIRION LTD.

Global Unique Device Identification Database

00382902560739	ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C
00382902560708	ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C
00382902560456	ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C
00382902560418	ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C
10304040019778	ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C
00608337000047	Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
00742860100215	ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C
00742860100147	ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C
00742860001901	ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C
00722066003343	Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
00855574005407	Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
30014613003175	ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C
30014613202547	ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C
30014613202189	ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C
30014613201830	ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C

Maude Adverse Events

BD VERITOR? SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT	BECTON, DICKINSON AND COMPANY	2018-12-24
BD VERITOR? SYSTEM FOR RAPID DETECTION OF FLU A+B, 30 TESTS	BECTON, DICKINSON & CO.	2018-03-13
BD VERITOR PHYSICIAN KIT - FLU A & B	BECTON, DICKINSON & CO.	2017-03-02
SOFIA INFLUENZA A+B	QUIDEL CORP.	2015-08-12
BD VERITOR SYSTEM - FLU A & B	BD DIAGNOSTICS SYSTEMS	2015-01-28
BD VERITOR PHYSICIAN KIT - FLU A AND B	BD DIAGNOSTIC SYSTEMS	2015-01-13
ALERE BINAXNOW INFLUENZA A&B CARD	ALERE SCARBOROUGH INC.	2014-04-15
SOFIA FLUORESCENT IMMUNOASSAY ANALYZER	QUIDEL CORP	2014-03-20
SOFIA FLUORESCENT IMMUNOASSAY ANALYZER	QUIDEL CORP.	2014-03-11
SOFIA INFLUENZA A+B FIA	QUIDEL CORP.	2012-12-28
SOFIA INFLUENZA A AND B FIA KIT	QUIDEL CORP	2012-12-11
SOFIA INFLUENZA A AND B FIA KIT	QUIDEL CORP	2012-12-11
SOFIA RAPID INFLUENZA A AND B TEST	QUIDEL	2012-11-16
SOFIA INFLUENZA A AND B RAPID TEST	GUIDEL	2012-11-16
BINAXNOW	ALERE SCARBOROUGH, INC.	2011-02-08
BINAXNOW	ALERE SCARBOROUGH, INC.	2011-01-05
BINAXNOW	INVERNESS MEDICAL	2010-03-15
BINAXNOW INFLUENZA A & B	BINAX, INC (D.B.A. INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS)	2006-12-12
Q-TEST INFLUENZA A	BECTON DICKINSON MICROBIOLOGY SYSTEM	1995-02-15

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