FDA Product Code GNW: Antisera, Cf, Influenza Virus A, B, C
Leading manufacturers include Diagnostic Hybrids, Inc., Gull Laboratories, Inc. and Baxter Healthcare Corp.
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
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