FDA Product Code
FDA Product Code OCC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.3980
510(k) Clearances — 80 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262747 | ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 | Abbott Diagnostics Scarborough, Inc. | 2026-08-31 | Special | PDF ↗ |
| K254139 | BioCode® Respiratory Pathogen Panel (RPP) | Applied BioCode, Inc. | 2026-05-01 | Traditional | PDF ↗ |
| K242613 | NxTAG® Respiratory Pathogen Panel | Luminex Molecular Diagnostics, Inc. | 2024-10-02 | Special | PDF ↗ |
| K232775 | ID NOW Influenza A & B 2 | Abbott Diagnostics Scarborough, Inc. | 2023-10-10 | Special | PDF ↗ |
| K231017 | Panther Fusion AdV/hMPV/RV Assay | Hologic, Inc. | 2023-05-05 | Special | PDF ↗ |
| K213822 | cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2022-07-06 | Special | PDF ↗ |
| K210234 | cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2021-02-16 | Special | PDF ↗ |
| K201505 | Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack | Diasorin Molecular, LLC | 2020-08-22 | Traditional | PDF ↗ |
| 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 | Roche Molecular Systems, Inc. | 2020-02-10 | Special | PDF ↗ |
| K192485 | BioCode Respiratory Pathogen Panel (RPP) | Applied BioCode, Inc. | 2019-12-23 | Traditional | PDF ↗ |
| K193167 | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software | Luminex Molecular Diagnostics, Inc. | 2019-12-11 | Special | PDF ↗ |
| K191729 | Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System | Roche Molecular Systems, Inc. | 2019-07-24 | Special | PDF ↗ |
| K191534 | ID NOW Influenza A & B 2 | Abbott Diagnostics Scarborough, Inc. | 2019-07-11 | Special | PDF ↗ |
| K183597 | QIAstat-Dx Respiratory Panel | QIAGEN GmbH | 2019-05-18 | Traditional | PDF ↗ |
| K181443 | Accula RSV Test | Mesa Biotech, Inc. | 2018-11-23 | Dual Track | PDF ↗ |
| 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 | Cepheid | 2018-08-15 | Traditional | PDF ↗ |
| K180218 | Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV | Cepheid | 2018-07-24 | Dual Track | PDF ↗ |
| K173932 | Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 | Alere Scarborough, Inc. | 2018-01-26 | Special | PDF ↗ |
| K171552 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV | Cepheid | 2017-12-19 | Dual Track | PDF ↗ |
| K172629 | Panther Fusion AdV/hMPV/RV Assay | Hologic, Inc. | 2017-12-04 | Traditional | PDF ↗ |
| K171974 | Solana RSV+hMPV Assay | Quidel Corporation | 2017-10-16 | Traditional | PDF ↗ |
| K171792 | Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit | Alere Scarborough, Inc. | 2017-09-29 | Traditional | PDF ↗ |
| 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 | Hologic, Inc. | 2017-09-26 | Traditional | PDF ↗ |
| K163628 | Idylla Respiratory (IFV-RSV) Panel | Janssen Pharmaceutica NV | 2017-08-30 | Traditional | PDF ↗ |
| K163636 | ePlex Respiratory Pathogen Panel | Genmark Diagnostics, Incorporated | 2017-06-09 | Traditional | PDF ↗ |
| K170604 | FilmArray Respiratory Panel 2 (RP2) | Biofire Diagnostics, LLC | 2017-05-30 | Traditional | PDF ↗ |
| 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 | Cepheid | 2017-02-13 | Traditional | PDF ↗ |
| 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 | Cepheid | 2017-02-09 | Traditional | PDF ↗ |
| K163266 | Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument | Alere Scarborough, Inc. | 2016-12-21 | Special | PDF ↗ |
| K152579 | FilmArray Respiratory Panel EZ (RP EZ) | Biofire Diagnostics, LLC | 2016-10-03 | Dual Track | PDF ↗ |
| K161814 | Solana Influenza A+B Assay | Quidel Corporation | 2016-09-27 | Traditional | PDF ↗ |
| K161375 | Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit | Alere Scarborough, Inc. | 2016-08-18 | Traditional | PDF ↗ |
| K161220 | ARIES® Flu A/B & RSV Assay | Luminex Corporation | 2016-08-02 | Traditional | PDF ↗ |
| K153544 | cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System | Iquum, Inc. | 2016-07-25 | Dual Track | PDF ↗ |
| K160068 | FilmArray Respiratory Panel (RP) for use with FilmArray Torch | Biofire Diagnostics, LLC | 2016-02-08 | Special | PDF ↗ |
| K152386 | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software | Luminex Molecular Diagnostics, Inc. | 2015-12-17 | Traditional | PDF ↗ |
| K151226 | Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) | Cepheid | 2015-12-03 | Dual Track | PDF ↗ |
| K153219 | ProFlu+ Assay | Hologic, Inc. | 2015-11-20 | Special | PDF ↗ |
| K152523 | JBAIDS Influenza A & B Detection Kit | U.S Army Medical Materiel Development Activity | 2015-10-01 | Special | PDF ↗ |
| K152408 | Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack | Focus Diagnostics, Inc. | 2015-09-21 | Special | PDF ↗ |
| K143653 | Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) | Nanosphere, Inc. | 2015-09-04 | Traditional | PDF ↗ |
| K151464 | Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit | Alere Scarborough, Inc. | 2015-07-28 | Traditional | PDF ↗ |
| K143080 | FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System | Biofire Diagnostics, LLC | 2015-02-17 | Traditional | PDF ↗ |
| K142365 | Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack | Focus Diagnostics | 2014-12-05 | Traditional | PDF ↗ |
| K142045 | XPERT FLU/RSV XC ASSAY | Cepheid | 2014-11-22 | Traditional | PDF ↗ |
| K141931 | LYRA ADENOVIRUS ASSAY | Quidel Corporation | 2014-10-09 | Traditional | PDF ↗ |
| K141520 | ALERE I INFLUENZA A & B | Alere Scarborough, Inc D/B/A Binax, Inc. | 2014-06-13 | Traditional | PDF ↗ |
| K131813 | QUIDEL MOLECULAR RSV + HMPV ASSAY | Quidel Corp. | 2013-09-06 | Traditional | PDF ↗ |
| K131584 | IMDX FLU A/B AND RSV FOR ABBOTT M2000 | Intelligent Medical Devices, Inc. | 2013-08-21 | Traditional | PDF ↗ |
| K132159 | PROADENO+ ASSAY | Gen-Probe Prodesse, Inc. | 2013-08-14 | Special | PDF ↗ |
| K132129 | PRODESSE PROFLU+ ASSAY | Gen-Probe Prodesse, Inc. | 2013-08-09 | Special | PDF ↗ |
| K123620 | FILMARRAY RESPIRATORY PANEL (RP) | Biofire Diagnostics, Inc. | 2013-02-11 | Traditional | PDF ↗ |
| K121942 | ADENOVIRUS R-GENE US | Argene SA | 2013-02-08 | Traditional | PDF ↗ |
| K123191 | XPERT FLU | Cepheid | 2012-12-21 | Traditional | PDF ↗ |
| K121003 | ABBOTT PLEX-ID FLU ASSAY | Abbott Laboratories | 2012-12-21 | Traditional | PDF ↗ |
| K120413 | SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK | Focus Diagnostics, Inc. | 2012-07-13 | Traditional | PDF ↗ |
| K120267 | FILMARRAY RP PANEL | Idaho Technology, Inc. | 2012-05-15 | Traditional | PDF ↗ |
| K112781 | TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I) | Luminex Molecular Diagnostics, Inc. | 2012-02-17 | Traditional | PDF ↗ |
| K113323 | ARTUS INFL A/B RG RT-PCR KIT | QIAGEN GmbH | 2012-02-06 | Traditional | PDF ↗ |
| K112172 | QUIDEL MOLECULAR INFLUENZA A + B ASSAY | Quidel Corp. | 2011-12-22 | Traditional | PDF ↗ |
| K111775 | JBAIDS INFLUENZA A&B DETECTION KIT | U.S. Army Medical Material Development Acitvity | 2011-09-13 | Traditional | PDF ↗ |
| K112199 | XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1) | Luminex Molecular Diagnostics, Inc. | 2011-09-01 | Special | PDF ↗ |
| K111387 | LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER | Iquum, Inc. | 2011-08-04 | Traditional | PDF ↗ |
| K103776 | XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST | Luminex Molecular Diagnostics, Inc. | 2011-07-01 | Traditional | PDF ↗ |
| K110968 | PROFLU+ ASSAY | Gen-Probe Prodesse, Inc. | 2011-06-27 | Traditional | PDF ↗ |
| K110764 | FILMARRAY RP PANEL | Idaho Technology, Inc. | 2011-04-27 | Traditional | PDF ↗ |
| K103175 | FILMARRAY RESPIRATORY PANEL (RP) | Idaho Technology, Inc. | 2011-02-17 | Traditional | PDF ↗ |
| K103209 | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+) | Nanosphere, Inc. | 2011-01-10 | Traditional | PDF ↗ |
| K102952 | PRODESSE PROADENO | Gen-Probe Prodesse, Inc. | 2010-12-03 | Traditional | PDF ↗ |
| K102170 | SIMPLEXA FLU A/B & RSV | Focus Diagnostics, Inc. | 2010-11-24 | Traditional | PDF ↗ |
| K093337 | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM | Nanosphere, Inc. | 2009-11-17 | Special | PDF ↗ |
| K092957 | VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST | Nanosphere, Inc. | 2009-10-21 | Special | PDF ↗ |
| K092566 | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP) | Nanosphere, Inc. | 2009-10-09 | Traditional | PDF ↗ |
| K092500 | MODIFICATION TO PROFLU+ ASSAY | Prodesse, Inc. | 2009-08-20 | Special | PDF ↗ |
| K091667 | XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116 | Luminex Molecular Diagnostics, Inc. | 2009-06-25 | Special | PDF ↗ |
| K083088 | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST | Nanosphere, Inc. | 2009-05-01 | Traditional | PDF ↗ |
| K081483 | XTAG RESPIRATORY VIRAL PANEL | Luminex Molecular Diagnostics, Inc. | 2008-06-25 | Special | PDF ↗ |
| K081030 | MODIFICATION TO PROFLU+ ASSAY | Prodesse, Inc. | 2008-05-02 | Special | PDF ↗ |
| K073029 | PROFLU+ ASSAY | Prodesse, Inc. | 2008-01-04 | Traditional | PDF ↗ |
| DEN070013 | ID-TAG RESPIRATORY VIRAL PANEL | Luminex Molecular Diagnostics, Inc. | 2008-01-03 | Post-NSE | — |
Product code OCC · Class II · Microbiology. Data: openFDA.