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 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 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 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 Jun 22, 2010
CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL
K101564
Centers For Disease Control and Prevention
Microbiology · 18d

About Product Code OQW - Regulatory Context