Panels › Microbiology › Product code OQW · Class 2
2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
Regulation 866.3332
0510(k)s in 12 months (10 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OQW
| Company | 510(k)s | Recalls |
|---|---|---|
| Centers for Disease Control and Prevention | 4 | 0 |
| Cepheid | 2 | 0 |
| Gen-Probe Prodesse, Inc. | 2 | 0 |
| Focus Diagnostics, Inc. | 1 | 0 |
| U.S Army Medical Materiel Development Activity | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 26, 2013 | K132237 | PRODESSE PROFAST+ ASSAY Gen-Probe Prodesse, Inc. | OQW |
| May 22, 2013 | K130551 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL Centers for Disease Control and Prevention | OQW |
| Jan 14, 2013 | K123905 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL Centers for Disease Control and Prevention | OQW |
| May 18, 2012 | K120911 | XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV) Cepheid | OQW |
| Sep 13, 2011 | K111778 | JBAIDS INFLUENZA A SUBTYPING KIT U.S Army Medical Materiel Development Activity | OQW |
| Aug 23, 2011 | K111507 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL Centers for Disease Control and Prevention | OQW |
| Apr 21, 2011 | K103766 | XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0 Cepheid | OQW |
| Jul 23, 2010 | K101855 | PROFAST+ ASSAY Gen-Probe Prodesse, Inc. | OQW |
| Jun 22, 2010 | K101564 | CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL Centers for Disease Control and Prevention | OQW |
| May 24, 2010 | K100148 | SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 Focus Diagnostics, Inc. | OQW |
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