GNX · Class I · 21 CFR 866.3330

FDA Product Code GNX: Antigens, Cf (including Cf Control), Influenza Virus A, B, C

Leading manufacturers include Quidel Corp., Whittaker Bioproducts, Inc. and Remel, Inc..

18
Total
18
Cleared
114d
Avg days
1981
Since

FDA 510(k) Cleared Antigens, Cf (including Cf Control), Influenza Virus A, B, C Devices (Product Code GNX)

18 devices
1–18 of 18
Cleared Dec 05, 2013
ALERE BINAXNOW INFLUENZA A & B CARD
K133411
Alere Scarborough, Inc D/B/A Binax, Inc.
Microbiology · 28d
Cleared Aug 22, 2013
SAS FLUALERT A & B, SAS INFLUENZA A TEST
K132352
Sa Scientific , Ltd.
Microbiology · 24d
Cleared Jul 12, 2013
REMEL XPECT FLU A&B
K131804
Remel, Inc.
Microbiology · 23d
Cleared Jul 05, 2013
QUICK VUE INFLUENZA
K131599
Quidel Corporation
Microbiology · 32d
Cleared Jul 05, 2013
SOFIA INFLUENZA A+B FIA
K131606
Quidel Corp.
Microbiology · 32d
Cleared Jun 28, 2013
QUICKVUE INFLUENZA A+B
K131619
Quidel Corp.
Microbiology · 25d
Cleared Nov 05, 2012
OSOM INFLUENZA A&B TEST MODEL 190
K123182
SEKISUI Diagnostics, LLC
Microbiology · 26d
Cleared Sep 10, 1997
VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES
K971494
Zymetx, Inc.
Microbiology · 139d
Cleared Dec 29, 1992
BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY
K924006
Baxter Healthcare Corp
Microbiology · 141d
Cleared Jun 27, 1990
FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B
K901493
Whittaker Bioproducts, Inc.
Microbiology · 90d
Cleared Jan 16, 1990
FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A
K893579
Whittaker Bioproducts, Inc.
Microbiology · 252d
Cleared Nov 22, 1988
INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION
K884191
Baxter Diagnostics, Inc.
Microbiology · 47d
Cleared Feb 24, 1988
IMAGEN INFLUENZA VIRUS A AND B TESTMI
K872958
Boots-Celltech Diagnostics, Inc.
Microbiology · 210d
Cleared Jan 12, 1981
INFLUENZA A & B S-ANTIGEN & CONTROLS
K802931
Orion Diagnostica, Inc.
Microbiology · 54d

About Product Code GNX - Regulatory Context