2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
The 2009 H1N1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification (product code OQW) is an in vitro diagnostic test used to directly detect and differentiate the 2009 H1N1 influenza virus from human respiratory specimens. It aids in the clinical diagnosis of H1N1 influenza infection during public health surveillance and outbreak response. As an FDA Class 2 device under regulation 866.3332, it requires 510(k) premarket clearance and falls within the Microbiology specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- OQW
- Device Class
- FDA class 2
- Regulation Number
- 866.3332
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K132237 | PRODESSE PROFAST+ ASSAY | Aug 26, 2013 | Substantially Equivalent | Gen-Probe Prodesse, Inc. |
| K130551 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | May 22, 2013 | Substantially Equivalent | Centers for Disease Control and Prevention |
| K123905 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | Jan 14, 2013 | Substantially Equivalent | Centers for Disease Control and Prevention |
| K120911 | XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV) | May 18, 2012 | Substantially Equivalent | Cepheid |
| K111778 | JBAIDS INFLUENZA A SUBTYPING KIT | Sep 13, 2011 | Substantially Equivalent | U.S Army Medical Materiel Development Activity |
| K111507 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | Aug 23, 2011 | Substantially Equivalent | Centers for Disease Control and Prevention |
| K103766 | XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0 | Apr 21, 2011 | Substantially Equivalent | Cepheid |
| K101855 | PROFAST+ ASSAY | Jul 23, 2010 | Substantially Equivalent | Gen-Probe Prodesse, Inc. |
| K101564 | CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL | Jun 22, 2010 | Substantially Equivalent | Centers for Disease Control and Prevention |
| K100148 | SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 | May 24, 2010 | Substantially Equivalent | Focus Diagnostics, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.