2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification
Microbiology · 21 CFR 866.3332
2009 H1N1 influenza virus detection and identification reagents are used to directly detect and differentiate the 2009 H1N1 influenza virus in human respiratory specimens
Recent MDR events
1 adverse event reports on file
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
3 firms currently registered for this product code
510(k) clearances
10 clearances for this product code
- Gen-Probe Prodesse, Inc.Aug 26, 2013
K132237 · PRODESSE PROFAST+ ASSAY
- Centers for Disease Control and PreventionMay 22, 2013
K130551 · CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
- Centers for Disease Control and PreventionJan 14, 2013
K123905 · CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
- CepheidMay 18, 2012
K120911 · XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)
- U.S Army Medical Materiel Development ActivitySep 13, 2011
K111778 · JBAIDS INFLUENZA A SUBTYPING KIT
- Centers for Disease Control and PreventionAug 23, 2011
K111507 · CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
- CepheidApr 21, 2011
K103766 · XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0
- Gen-Probe Prodesse, Inc.Jul 23, 2010
K101855 · PROFAST+ ASSAY