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
Cleared
Oct 21, 2009
D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT
Diagnostic Hybrids, Inc.
Microbiology
33d
Cleared
Aug 28, 2009
MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
Diagnostic Hybrids, Inc.
Microbiology
30d
Cleared
Dec 23, 2008
D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT
Diagnostic Hybrids, Inc.
Microbiology
187d
Cleared
Nov 20, 2006
D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
Diagnostic Hybrids, Inc.
Microbiology
214d
Cleared
Dec 18, 2002
DFA RESPIRATORY VIRUS SCREENING & ID KIT
Diagnostic Hybrids, Inc.
Microbiology
126d
Cleared
Nov 07, 2000
BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT
Intracel Corp.
Microbiology
25d
Cleared
Apr 08, 1998
LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B
Light Diagnostics
Microbiology
142d
Cleared
Dec 22, 1997
IMAGEN RESPIRATORY SCREEN
Dako Diagnostics , Ltd.
Microbiology
74d
Cleared
Dec 26, 1996
IMAGEN RESPIRATORY SCREEN
Dako Diagnostics , Ltd.
Microbiology
216d
Cleared
Jul 06, 1994
INFLUENZA A ANTIGEN TEST
Neogenex
Microbiology
62d
Cleared
Jun 30, 1994
INFLUENZA B ANITGEN TEST
Neogenex
Microbiology
56d
Cleared
Dec 17, 1991
INFLUENZA MAB TEST/INFLUENZA A TEST
Gull Laboratories, Inc.
Microbiology
144d
Cleared
Dec 13, 1991
INFLUENZA MAB TEST/INFLUENZA B TEST
Gull Laboratories, Inc.
Microbiology
147d
Cleared
Feb 02, 1990
VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODY
Baxter Healthcare Corp
Microbiology
72d
Cleared
Sep 18, 1987
INFLUENZA B VIRUS CF ANTIGEN AND CONTROL ANTIGEN
Sita, Inc.
Microbiology
73d
Cleared
Sep 18, 1987
YNFLUENZA A VIRUS CF ANTIGEN AND CONTROL ANTIGEN
Sita, Inc.
Microbiology
73d