Panels › Microbiology › Product code OCC · Class 2
Respiratory Virus Panel Nucleic Acid Assay System
Regulation 866.3980
3510(k)s in 12 months (81 all time)
0recalls in 12 months (25 all time)
23recalls that name a 510(k)
Top companies in OCC
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 14, 2013 | K132159 | PROADENO+ ASSAY Gen-Probe Prodesse, Inc. | OCC |
| Aug 9, 2013 | K132129 | PRODESSE PROFLU+ ASSAY Gen-Probe Prodesse, Inc. | OCC |
| Feb 11, 2013 | K123620 | FILMARRAY RESPIRATORY PANEL (RP) Biofire Diagnostics, Inc. | OCC |
| Feb 8, 2013 | K121942 | ADENOVIRUS R-GENE US Argene SA, FR | OCC |
| Dec 21, 2012 | K123191 | XPERT FLU Cepheid | OCC |
| Dec 21, 2012 | K121003 | ABBOTT PLEX-ID FLU ASSAY Abbott Laboratories | OCC |
| Jul 13, 2012 | K120413 | SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK Focus Diagnostics, Inc. | OCC |
| May 15, 2012 | K120267 | FILMARRAY RP PANEL Idaho Technology, Inc. | OCC |
| Feb 17, 2012 | K112781 | TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I) Luminex Molecular Diagnostics, Inc., CA | OCC |
| Feb 6, 2012 | K113323 | ARTUS INFL A/B RG RT-PCR KIT QIAGEN GmbH | OCC |
| Dec 22, 2011 | K112172 | QUIDEL MOLECULAR INFLUENZA A + B ASSAY Quidel Corp. | OCC |
| Sep 13, 2011 | K111775 | JBAIDS INFLUENZA A&B DETECTION KIT U.S. Army Medical Material Development Acitvity | OCC |
| Sep 1, 2011 | K112199 | XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1) Luminex Molecular Diagnostics, Inc., CA | OCC |
| Aug 4, 2011 | K111387 | LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER Iquum, Inc. | OCC |
| Jul 1, 2011 | K103776 | XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST Luminex Molecular Diagnostics, Inc., CA | OCC |
| Jun 27, 2011 | K110968 | PROFLU+ ASSAY Gen-Probe Prodesse, Inc. | OCC |
| Apr 27, 2011 | K110764 | FILMARRAY RP PANEL Idaho Technology, Inc. | OCC |
| Feb 17, 2011 | K103175 | FILMARRAY RESPIRATORY PANEL (RP) Idaho Technology, Inc. | OCC |
| Jan 10, 2011 | K103209 | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+) Nanosphere, Inc. | OCC |
| Dec 3, 2010 | K102952 | PRODESSE PROADENO Gen-Probe Prodesse, Inc. | OCC |
| Nov 24, 2010 | K102170 | SIMPLEXA FLU A/B & RSV Focus Diagnostics, Inc. | OCC |
| Nov 17, 2009 | K093337 | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM Nanosphere, Inc. | OCC |
| Oct 21, 2009 | K092957 | VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST Nanosphere, Inc. | OCC |
| Oct 9, 2009 | K092566 | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP) Nanosphere, Inc. | OCC |
| Aug 20, 2009 | K092500 | MODIFICATION TO PROFLU+ ASSAY Prodesse, Inc. | OCC |
| Jun 25, 2009 | K091667 | XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116 Luminex Molecular Diagnostics, Inc., CA | OCC |
| May 1, 2009 | K083088 | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST Nanosphere, Inc. | OCC |
| Jun 25, 2008 | K081483 | XTAG RESPIRATORY VIRAL PANEL Luminex Molecular Diagnostics, Inc., CA | OCC |
| May 2, 2008 | K081030 | MODIFICATION TO PROFLU+ ASSAY Prodesse, Inc. | OCC |
| Jan 4, 2008 | K073029 | PROFLU+ ASSAY Prodesse, Inc. | OCC |
| Jan 3, 2008 | DEN070013 | ID-TAG RESPIRATORY VIRAL PANEL Luminex Molecular Diagnostics, Inc., CA | OCC |
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