OQW — 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification Class II
Classification Details
- Product Code
- OQW
- Device Class
- Class II
- Regulation Number
- 866.3332
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
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 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K132237 | gen-probe prodesse | PRODESSE PROFAST+ ASSAY | August 26, 2013 |
| K130551 | centers for disease control and prevention | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | May 22, 2013 |
| K123905 | centers for disease control and prevention | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | January 14, 2013 |
| K120911 | cepheid | XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV) | May 18, 2012 |
| K111778 | u.s army medical materiel development activity | JBAIDS INFLUENZA A SUBTYPING KIT | September 13, 2011 |
| K111507 | centers for disease control and prevention | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | August 23, 2011 |
| K103766 | cepheid | XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOF | April 21, 2011 |
| K101855 | gen-probe prodesse | PROFAST+ ASSAY | July 23, 2010 |
| K101564 | centers for disease control and prevention | CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL | June 22, 2010 |
| K100148 | focus diagnostics | SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 | May 24, 2010 |