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., Quidel Corporation and Baxter Diagnostics, 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 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 Dec 29, 1992
BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY
K924006
Baxter Healthcare Corp
Microbiology · 141d
Cleared Nov 22, 1988
INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION
K884191
Baxter Diagnostics, Inc.
Microbiology · 47d

About Product Code GNX - Regulatory Context