OQW — 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification Class II
FDA product code OQW covers "2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification", a Class II medical device regulated under 21 CFR 866.3332. Submissions are reviewed by the Microbiology panel. At least 10 recent 510(k) clearances have been granted under this product code.
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 |