GNW · Class I · 21 CFR 866.3330

FDA Product Code GNW: Antisera, Cf, Influenza Virus A, B, C

Leading manufacturers include Diagnostic Hybrids, Inc., Gull Laboratories, Inc. and Neogenex.

16
Total
16
Cleared
105d
Avg days
1987
Since

FDA 510(k) Cleared Antisera, Cf, Influenza Virus A, B, C Devices (Product Code GNW)

16 devices
1–16 of 16
Cleared Oct 21, 2009
D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT
K092882
Diagnostic Hybrids, Inc.
Microbiology · 33d
Cleared Aug 28, 2009
MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
K092300
Diagnostic Hybrids, Inc.
Microbiology · 30d
Cleared Dec 23, 2008
D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT
K081746
Diagnostic Hybrids, Inc.
Microbiology · 187d
Cleared Nov 20, 2006
D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
K061101
Diagnostic Hybrids, Inc.
Microbiology · 214d
Cleared Dec 18, 2002
DFA RESPIRATORY VIRUS SCREENING & ID KIT
K022713
Diagnostic Hybrids, Inc.
Microbiology · 126d
Cleared Apr 08, 1998
LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B
K974302
Light Diagnostics
Microbiology · 142d
Cleared Dec 22, 1997
IMAGEN RESPIRATORY SCREEN
K973954
Dako Diagnostics , Ltd.
Microbiology · 74d
Cleared Dec 26, 1996
IMAGEN RESPIRATORY SCREEN
K962037
Dako Diagnostics , Ltd.
Microbiology · 216d
Cleared Jul 06, 1994
INFLUENZA A ANTIGEN TEST
K942172
Neogenex
Microbiology · 62d
Cleared Jun 30, 1994
INFLUENZA B ANITGEN TEST
K942174
Neogenex
Microbiology · 56d
Cleared Dec 17, 1991
INFLUENZA MAB TEST/INFLUENZA A TEST
K913351
Gull Laboratories, Inc.
Microbiology · 144d
Cleared Dec 13, 1991
INFLUENZA MAB TEST/INFLUENZA B TEST
K913214
Gull Laboratories, Inc.
Microbiology · 147d
Cleared Feb 02, 1990
VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODY
K896635
Baxter Healthcare Corp
Microbiology · 72d

About Product Code GNW - Regulatory Context