OQW · Class II · 21 CFR 866.3332

FDA Product Code OQW: 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification

2009 H1n1 Influenza Virus Detection And Identification Reagents Are Used To Directly Detect And Differentiate The 2009 H1n1 Influenza Virus In Human Respiratory Specimens

Leading manufacturers include Centers For Disease Control and Prevention, Gen-Probe Prodesse, Inc. and Cepheid.

10
Total
10
Cleared
65d
Avg days
2010
Since

FDA 510(k) Cleared 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification Devices (Product Code OQW)

10 devices
1–10 of 10
Cleared Aug 26, 2013
PRODESSE PROFAST+ ASSAY
K132237
Gen-Probe Prodesse, Inc.
Microbiology · 39d
Cleared May 22, 2013
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
K130551
Centers For Disease Control and Prevention
Microbiology · 79d
Cleared Jan 14, 2013
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
K123905
Centers For Disease Control and Prevention
Microbiology · 26d
Cleared May 18, 2012
XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)
K120911
Cepheid
Microbiology · 53d
Cleared Sep 13, 2011
JBAIDS INFLUENZA A SUBTYPING KIT
K111778
U.S Army Medical Materiel Development Activity
Microbiology · 82d
Cleared Aug 23, 2011
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
K111507
Centers For Disease Control and Prevention
Microbiology · 83d
Cleared Apr 21, 2011
XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0
K103766
Cepheid
Microbiology · 119d
Cleared Jul 23, 2010
PROFAST+ ASSAY
K101855
Gen-Probe Prodesse, Inc.
Microbiology · 22d
Cleared Jun 22, 2010
CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL
K101564
Centers For Disease Control and Prevention
Microbiology · 18d
Cleared May 24, 2010
SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500
K100148
Focus Diagnostics, Inc.
Microbiology · 125d

About Product Code OQW - Regulatory Context