| BioCode® Respiratory Pathogen Panel (RPP) (K254139) | Applied BioCode, Inc. | 2026-05-01 |
| NxTAG® Respiratory Pathogen Panel (K242613) | Luminex Molecular Diagnostics, Inc. | 2024-10-02 |
| ID NOW Influenza A & B 2 (K232775) | Abbott Diagnostics Scarborough, Inc. | 2023-10-10 |
| Panther Fusion AdV/hMPV/RV Assay (K231017) | Hologic, Inc. | 2023-05-05 |
| cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System (K213822) | Roche Molecular Systems, Inc. | 2022-07-06 |
| cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System (K210234) | Roche Molecular Systems, Inc. | 2021-02-16 |
| Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack (K201505) | Diasorin Molecular, LLC | 2020-08-22 |
| 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 (K200065) | Roche Molecular Systems, Inc. | 2020-02-10 |
| BioCode Respiratory Pathogen Panel (RPP) (K192485) | Applied BioCode, Inc. | 2019-12-23 |
| NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software (K193167) | Luminex Molecular Diagnostics, Inc. | 2019-12-11 |
| Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System (K191729) | Roche Molecular Systems, Inc. | 2019-07-24 |
| ID NOW Influenza A & B 2 (K191534) | Abbott Diagnostics Scarborough, Inc. | 2019-07-11 |
| QIAstat-Dx Respiratory Panel (K183597) | QIAGEN GmbH | 2019-05-18 |
| Accula RSV Test (K181443) | Mesa Biotech, Inc. | 2018-11-23 |
| 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 (K181289) | Cepheid | 2018-08-15 |
| Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV (K180218) | Cepheid | 2018-07-24 |
| Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 (K173932) | Alere Scarborough, Inc. | 2018-01-26 |
| Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV (K171552) | Cepheid | 2017-12-19 |
| Panther Fusion AdV/hMPV/RV Assay (K172629) | Hologic, Inc. | 2017-12-04 |
| Solana RSV+hMPV Assay (K171974) | Quidel Corporation | 2017-10-16 |
| Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit (K171792) | Alere Scarborough, Inc. | 2017-09-29 |
| Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes (K171963) | Hologic, Inc. | 2017-09-26 |
| Idylla Respiratory (IFV-RSV) Panel (K163628) | Janssen Pharmaceutica NV | 2017-08-30 |
| ePlex Respiratory Pathogen Panel (K163636) | Genmark Diagnostics, Incorporated | 2017-06-09 |
| FilmArray Respiratory Panel 2 (RP2) (K170604) | Biofire Diagnostics, LLC | 2017-05-30 |
| 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 (K162456) | Cepheid | 2017-02-13 |
| 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 (K162331) | Cepheid | 2017-02-09 |
| Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument (K163266) | Alere Scarborough, Inc. | 2016-12-21 |
| FilmArray Respiratory Panel EZ (RP EZ) (K152579) | Biofire Diagnostics, LLC | 2016-10-03 |
| Solana Influenza A+B Assay (K161814) | Quidel Corporation | 2016-09-27 |
| Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit (K161375) | Alere Scarborough, Inc. | 2016-08-18 |
| ARIES® Flu A/B & RSV Assay (K161220) | Luminex Corporation | 2016-08-02 |
| cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System (K153544) | Iquum, Inc. | 2016-07-25 |
| FilmArray Respiratory Panel (RP) for use with FilmArray Torch (K160068) | Biofire Diagnostics, LLC | 2016-02-08 |
| NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software (K152386) | Luminex Molecular Diagnostics, Inc. | 2015-12-17 |
| Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) (K151226) | Cepheid | 2015-12-03 |
| ProFlu+ Assay (K153219) | Hologic, Inc. | 2015-11-20 |
| JBAIDS Influenza A & B Detection Kit (K152523) | U.S Army Medical Materiel Development Activity | 2015-10-01 |
| Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack (K152408) | Focus Diagnostics, Inc. | 2015-09-21 |
| Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) (K143653) | Nanosphere, Inc. | 2015-09-04 |
| Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit (K151464) | Alere Scarborough, Inc. | 2015-07-28 |
| FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System (K143080) | Biofire Diagnostics, LLC | 2015-02-17 |
| Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack (K142365) | Focus Diagnostics | 2014-12-05 |
| XPERT FLU/RSV XC ASSAY (K142045) | Cepheid | 2014-11-22 |
| LYRA ADENOVIRUS ASSAY (K141931) | Quidel Corporation | 2014-10-09 |
| ALERE I INFLUENZA A & B (K141520) | Alere Scarborough, Inc D/B/A Binax, Inc. | 2014-06-13 |
| QUIDEL MOLECULAR RSV + HMPV ASSAY (K131813) | Quidel Corp. | 2013-09-06 |
| IMDX FLU A/B AND RSV FOR ABBOTT M2000 (K131584) | Intelligent Medical Devices, Inc. | 2013-08-21 |
| PROADENO+ ASSAY (K132159) | Gen-Probe Prodesse, Inc. | 2013-08-14 |
| PRODESSE PROFLU+ ASSAY (K132129) | Gen-Probe Prodesse, Inc. | 2013-08-09 |
| FILMARRAY RESPIRATORY PANEL (RP) (K123620) | Biofire Diagnostics, Inc. | 2013-02-11 |
| ADENOVIRUS R-GENE US (K121942) | Argene SA | 2013-02-08 |
| XPERT FLU (K123191) | Cepheid | 2012-12-21 |
| ABBOTT PLEX-ID FLU ASSAY (K121003) | Abbott Laboratories | 2012-12-21 |
| SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK (K120413) | Focus Diagnostics, Inc. | 2012-07-13 |
| FILMARRAY RP PANEL (K120267) | Idaho Technology, Inc. | 2012-05-15 |
| TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I) (K112781) | Luminex Molecular Diagnostics, Inc. | 2012-02-17 |
| ARTUS INFL A/B RG RT-PCR KIT (K113323) | QIAGEN GmbH | 2012-02-06 |
| QUIDEL MOLECULAR INFLUENZA A + B ASSAY (K112172) | Quidel Corp. | 2011-12-22 |
| JBAIDS INFLUENZA A&B DETECTION KIT (K111775) | U.S. Army Medical Material Development Acitvity | 2011-09-13 |
| XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1) (K112199) | Luminex Molecular Diagnostics, Inc. | 2011-09-01 |
| LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER (K111387) | Iquum, Inc. | 2011-08-04 |
| XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST (K103776) | Luminex Molecular Diagnostics, Inc. | 2011-07-01 |
| PROFLU+ ASSAY (K110968) | Gen-Probe Prodesse, Inc. | 2011-06-27 |
| FILMARRAY RP PANEL (K110764) | Idaho Technology, Inc. | 2011-04-27 |
| FILMARRAY RESPIRATORY PANEL (RP) (K103175) | Idaho Technology, Inc. | 2011-02-17 |
| VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+) (K103209) | Nanosphere, Inc. | 2011-01-10 |
| PRODESSE PROADENO (K102952) | Gen-Probe Prodesse, Inc. | 2010-12-03 |
| SIMPLEXA FLU A/B & RSV (K102170) | Focus Diagnostics, Inc. | 2010-11-24 |
| VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (K093337) | Nanosphere, Inc. | 2009-11-17 |
| VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST (K092957) | Nanosphere, Inc. | 2009-10-21 |
| VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP) (K092566) | Nanosphere, Inc. | 2009-10-09 |
| MODIFICATION TO PROFLU+ ASSAY (K092500) | Prodesse, Inc. | 2009-08-20 |
| XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116 (K091667) | Luminex Molecular Diagnostics, Inc. | 2009-06-25 |
| VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST (K083088) | Nanosphere, Inc. | 2009-05-01 |
| XTAG RESPIRATORY VIRAL PANEL (K081483) | Luminex Molecular Diagnostics, Inc. | 2008-06-25 |
| MODIFICATION TO PROFLU+ ASSAY (K081030) | Prodesse, Inc. | 2008-05-02 |
| PROFLU+ ASSAY (K073029) | Prodesse, Inc. | 2008-01-04 |
| ID-TAG RESPIRATORY VIRAL PANEL (DEN070013) | Luminex Molecular Diagnostics, Inc. | 2008-01-03 |