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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)
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Top companies in OCC

Company510(k)sRecalls
Luminex Molecular Diagnostics, Inc.92
Cepheid80
Luminex Corporation17
Biofire Diagnostics, Inc.52
Focus Diagnostics43
Nanosphere, Inc.61
Roche Molecular Systems, Inc.43
Quidel Corp.51
Abbott Diagnostics Scarborough, Inc.32
Alere Scarborough, Inc.50
Decided510(k)Device and applicantCode
Oct 21, 2026K261347DASH Flu A/B Test
Nuclein, LLC
OCC
Aug 31, 2026K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0
Abbott Diagnostics Scarborough, Inc.
OCC
May 1, 2026K254139BioCode® Respiratory Pathogen Panel (RPP)
Applied BioCode, Inc.
OCC
Oct 2, 2024K242613NxTAG® Respiratory Pathogen Panel
Luminex Molecular Diagnostics, Inc., CA
OCC
Oct 10, 2023K232775ID NOW Influenza A & B 2
Abbott Diagnostics Scarborough, Inc.
OCC
May 5, 2023K231017Panther Fusion AdV/hMPV/RV Assay
Hologic, Inc.
OCC
Jul 6, 2022K213822cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System
Roche Molecular Systems, Inc.
OCC
Feb 16, 2021K210234cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System
Roche Molecular Systems, Inc.
OCC
Aug 22, 2020K201505Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack
Diasorin Molecular, LLC
OCC
Feb 10, 2020K200065cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for
Roche Molecular Systems, Inc.
OCC
Dec 23, 2019K192485BioCode Respiratory Pathogen Panel (RPP)
Applied BioCode, Inc.
OCC
Dec 11, 2019K193167NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
Luminex Molecular Diagnostics, Inc., CA
OCC
Jul 24, 2019K191729Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System
Roche Molecular Systems, Inc.
OCC
Jul 11, 2019K191534ID NOW Influenza A & B 2
Abbott Diagnostics Scarborough, Inc.
OCC
May 18, 2019K183597QIAstat-Dx Respiratory Panel
QIAGEN GmbH, DE
OCC
Nov 23, 2018K181443Accula RSV Test
Mesa Biotech, Inc.
OCC
Aug 15, 2018K181289Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (G
Cepheid
OCC
Jul 24, 2018K180218Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II
Cepheid
OCC
Jan 26, 2018K173932Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2
Alere Scarborough, Inc.
OCC
Dec 19, 2017K171552Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, Ge
Cepheid
OCC
Dec 4, 2017K172629Panther Fusion AdV/hMPV/RV Assay
Hologic, Inc.
OCC
Oct 16, 2017K171974Solana RSV+hMPV Assay
Quidel Corporation
OCC
Sep 29, 2017K171792Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit
Alere Scarborough, Inc.
OCC
Sep 26, 2017K171963Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusi
Hologic, Inc.
OCC
Aug 30, 2017K163628Idylla Respiratory (IFV-RSV) Panel
Janssen Pharmaceutica NV, BE
OCC
Jun 9, 2017K163636ePlex Respiratory Pathogen Panel
Genmark Diagnostics, Incorporated
OCC
May 30, 2017K170604FilmArray Respiratory Panel 2 (RP2)
Biofire Diagnostics, LLC
OCC
Feb 13, 2017K162456Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpe
Cepheid
OCC
Feb 9, 2017K162331Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), Gen
Cepheid
OCC
Dec 21, 2016K163266Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument
Alere Scarborough, Inc.
OCC
Oct 3, 2016K152579FilmArray Respiratory Panel EZ (RP EZ)
Biofire Diagnostics, LLC
OCC
Sep 27, 2016K161814Solana Influenza A+B Assay
Quidel Corporation
OCC
Aug 18, 2016K161375Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit
Alere Scarborough, Inc.
OCC
Aug 2, 2016K161220ARIES® Flu A/B & RSV Assay
Luminex Corporation
OCC
Jul 25, 2016K153544cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System
Iquum, Inc.
OCC
Feb 8, 2016K160068FilmArray Respiratory Panel (RP) for use with FilmArray Torch
Biofire Diagnostics, LLC
OCC
Dec 17, 2015K152386NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
Luminex Molecular Diagnostics, Inc., CA
OCC
Dec 3, 2015K151226Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I)
Cepheid
OCC
Nov 20, 2015K153219ProFlu+ Assay
Hologic, Inc.
OCC
Oct 1, 2015K152523JBAIDS Influenza A & B Detection Kit
U.S Army Medical Materiel Development Activity
OCC
Sep 21, 2015K152408Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack
Focus Diagnostics, Inc.
OCC
Sep 4, 2015K143653Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)
Nanosphere, Inc.
OCC
Jul 28, 2015K151464Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit
Alere Scarborough, Inc.
OCC
Feb 17, 2015K143080FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System
Biofire Diagnostics, LLC
OCC
Dec 5, 2014K142365Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack
Focus Diagnostics
OCC
Nov 22, 2014K142045XPERT FLU/RSV XC ASSAY
Cepheid
OCC
Oct 9, 2014K141931LYRA ADENOVIRUS ASSAY
Quidel Corporation
OCC
Jun 13, 2014K141520ALERE I INFLUENZA A & B
Alere Scarborough, Inc D/B/A Binax, Inc.
OCC
Sep 6, 2013K131813QUIDEL MOLECULAR RSV + HMPV ASSAY
Quidel Corp.
OCC
Aug 21, 2013K131584IMDX FLU A/B AND RSV FOR ABBOTT M2000
Intelligent Medical Devices, Inc.
OCC

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