510(k) clearances for Respiratory Virus Panel Nucleic Acid Assay System

79 on file

Applied BioCode, Inc.May 1, 2026
K254139 · BioCode® Respiratory Pathogen Panel (RPP)
Luminex Molecular Diagnostics, Inc.Oct 2, 2024
K242613 · NxTAG® Respiratory Pathogen Panel
Abbott Diagnostics Scarborough, Inc.Oct 10, 2023
K232775 · ID NOW Influenza A & B 2
Hologic, Inc.May 5, 2023
K231017 · Panther Fusion AdV/hMPV/RV Assay
Roche Molecular Systems, Inc.Jul 6, 2022
K213822 · cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System
Roche Molecular Systems, Inc.Feb 16, 2021
K210234 · cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System
Diasorin Molecular, LLCAug 22, 2020
K201505 · Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack
Roche Molecular Systems, Inc.Feb 10, 2020
K200065 · cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System
Applied BioCode, Inc.Dec 23, 2019
K192485 · BioCode Respiratory Pathogen Panel (RPP)
Luminex Molecular Diagnostics, Inc.Dec 11, 2019
K193167 · NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
Roche Molecular Systems, Inc.Jul 24, 2019
K191729 · Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System
Abbott Diagnostics Scarborough, Inc.Jul 11, 2019
K191534 · ID NOW Influenza A & B 2
QIAGEN GmbHMay 18, 2019
K183597 · QIAstat-Dx Respiratory Panel
Mesa Biotech, Inc.Nov 23, 2018
K181443 · Accula RSV Test
CepheidAug 15, 2018
K181289 · Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System
CepheidJul 24, 2018
K180218 · Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
Alere Scarborough, Inc.Jan 26, 2018
K173932 · Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2
CepheidDec 19, 2017
K171552 · Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
Hologic, Inc.Dec 4, 2017
K172629 · Panther Fusion AdV/hMPV/RV Assay
Quidel CorporationOct 16, 2017
K171974 · Solana RSV+hMPV Assay
Alere Scarborough, Inc.Sep 29, 2017
K171792 · Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit
Hologic, Inc.Sep 26, 2017
K171963 · Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes
Janssen Pharmaceutica NVAug 30, 2017
K163628 · Idylla Respiratory (IFV-RSV) Panel
Genmark Diagnostics, IncorporatedJun 9, 2017
K163636 · ePlex Respiratory Pathogen Panel
Biofire Diagnostics, LLCMay 30, 2017
K170604 · FilmArray Respiratory Panel 2 (RP2)
CepheidFeb 13, 2017
K162456 · Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
CepheidFeb 9, 2017
K162331 · Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
Alere Scarborough, Inc.Dec 21, 2016
K163266 · Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument
Biofire Diagnostics, LLCOct 3, 2016
K152579 · FilmArray Respiratory Panel EZ (RP EZ)
Quidel CorporationSep 27, 2016
K161814 · Solana Influenza A+B Assay
Alere Scarborough, Inc.Aug 18, 2016
K161375 · Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit
Luminex CorporationAug 2, 2016
K161220 · ARIES® Flu A/B & RSV Assay
Iquum, Inc.Jul 25, 2016
K153544 · cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System
Biofire Diagnostics, LLCFeb 8, 2016
K160068 · FilmArray Respiratory Panel (RP) for use with FilmArray Torch
Luminex Molecular Diagnostics, Inc.Dec 17, 2015
K152386 · NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
CepheidDec 3, 2015
K151226 · Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I)
Hologic, Inc.Nov 20, 2015
K153219 · ProFlu+ Assay
U.S Army Medical Materiel Development ActivityOct 1, 2015
K152523 · JBAIDS Influenza A & B Detection Kit
Focus Diagnostics, Inc.Sep 21, 2015
K152408 · Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack
Nanosphere, Inc.Sep 4, 2015
K143653 · Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)
Alere Scarborough, Inc.Jul 28, 2015
K151464 · Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit
Biofire Diagnostics, LLCFeb 17, 2015
K143080 · FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System
Focus DiagnosticsDec 5, 2014
K142365 · Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack
CepheidNov 22, 2014
K142045 · XPERT FLU/RSV XC ASSAY
Quidel CorporationOct 9, 2014
K141931 · LYRA ADENOVIRUS ASSAY
Alere Scarborough, Inc D/B/A Binax, Inc.Jun 13, 2014
K141520 · ALERE I INFLUENZA A & B
Quidel Corp.Sep 6, 2013
K131813 · QUIDEL MOLECULAR RSV + HMPV ASSAY
Intelligent Medical Devices, Inc.Aug 21, 2013
K131584 · IMDX FLU A/B AND RSV FOR ABBOTT M2000
Gen-Probe Prodesse, Inc.Aug 14, 2013
K132159 · PROADENO+ ASSAY
Gen-Probe Prodesse, Inc.Aug 9, 2013
K132129 · PRODESSE PROFLU+ ASSAY
Biofire Diagnostics, Inc.Feb 11, 2013
K123620 · FILMARRAY RESPIRATORY PANEL (RP)
Argene SAFeb 8, 2013
K121942 · ADENOVIRUS R-GENE US
CepheidDec 21, 2012
K123191 · XPERT FLU
Abbott LaboratoriesDec 21, 2012
K121003 · ABBOTT PLEX-ID FLU ASSAY
Focus Diagnostics, Inc.Jul 13, 2012
K120413 · SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK
Idaho Technology, Inc.May 15, 2012
K120267 · FILMARRAY RP PANEL
Luminex Molecular Diagnostics, Inc.Feb 17, 2012
K112781 · TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I)
QIAGEN GmbHFeb 6, 2012
K113323 · ARTUS INFL A/B RG RT-PCR KIT
Quidel Corp.Dec 22, 2011
K112172 · QUIDEL MOLECULAR INFLUENZA A + B ASSAY
U.S. Army Medical Material Development AcitvitySep 13, 2011
K111775 · JBAIDS INFLUENZA A&B DETECTION KIT
Luminex Molecular Diagnostics, Inc.Sep 1, 2011
K112199 · XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)
Iquum, Inc.Aug 4, 2011
K111387 · LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER
Luminex Molecular Diagnostics, Inc.Jul 1, 2011
K103776 · XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST
Gen-Probe Prodesse, Inc.Jun 27, 2011
K110968 · PROFLU+ ASSAY
Idaho Technology, Inc.Apr 27, 2011
K110764 · FILMARRAY RP PANEL
Idaho Technology, Inc.Feb 17, 2011
K103175 · FILMARRAY RESPIRATORY PANEL (RP)
Nanosphere, Inc.Jan 10, 2011
K103209 · VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)
Gen-Probe Prodesse, Inc.Dec 3, 2010
K102952 · PRODESSE PROADENO
Focus Diagnostics, Inc.Nov 24, 2010
K102170 · SIMPLEXA FLU A/B & RSV
Nanosphere, Inc.Nov 17, 2009
K093337 · VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM
Nanosphere, Inc.Oct 21, 2009
K092957 · VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST
Nanosphere, Inc.Oct 9, 2009
K092566 · VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP)
Prodesse, Inc.Aug 20, 2009
K092500 · MODIFICATION TO PROFLU+ ASSAY
Luminex Molecular Diagnostics, Inc.Jun 25, 2009
K091667 · XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116
Nanosphere, Inc.May 1, 2009
K083088 · VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST
Luminex Molecular Diagnostics, Inc.Jun 25, 2008
K081483 · XTAG RESPIRATORY VIRAL PANEL
Prodesse, Inc.May 2, 2008
K081030 · MODIFICATION TO PROFLU+ ASSAY
Prodesse, Inc.Jan 4, 2008
K073029 · PROFLU+ ASSAY
Luminex Molecular Diagnostics, Inc.Jan 3, 2008
DEN070013 · ID-TAG RESPIRATORY VIRAL PANEL