Microbiology

List of Microbial Tests

MicroorganismTrade NameManufacturerSubmission
AdenovirusAdenovirus R-gene USArgene SAK121942
Lyra Adenovirus AssayQuidel CorportationK141931
ProAdeno+ AssayGen-Probe Prodesse, Inc.K102952
Prodesse ProAdeno + AssayGen-Probe Prodesse, Inc.K132159
Antimicrobial resistanceGenePOC CarbaGenePOC Inc.K190275
Bacillus AnthracisJBAIDS Anthrax Detection SystemIdaho Technology, Inc.K131930K071188K051713
Bacillus AnthracisB. anthracis Real-time PCR AssayCenters for Disease Control and PreventionK192871
Bacterial vaginosis (BV) markersAptima BV AssayHologic, Inc.K190452
BordetellaARIES Bordetella Assay; ARIES Bordetella Assay Protocol File KitLuminex CorporationK163626K163626/S001
AMPLIVUE BORDETELLA ASSAYQUIDEL CORPORATIONK143206
Great Basin Bordetella Direct TestGreat Basin Scientific, Inc.K170284
ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT ILLUMIPRO-10 AUTOMATED ISOTHERMAMERIDIAN BIOSCIENCE, INC.K133673K152285
SIMPLEXA BORDETELLA DIRECT, SIMPLEXA BORDETELLA POSITIVE CONTROL PACKDIASORIN MOLECULAR LLCK173498
SIMPLEXA BORDETELLA DIRECT, SIMPLEXA BORDETELLA POSITIVE CONTROL PACKDIASORIN MOLECULAR LLCK183223
Candida tropicalis / Candida albicans / Candida parapsilosis / Candida glabrata / Candida krusei  Affirm VPIII Microbial Identification TestMicroprobe Corp.K931151K931374
Yeast Traffic Light PNA FISHAdvanDx, Inc.K093024K080719
C. albicans / C. glabrata PNA FISHAdvanDx, Inc.K092784
C. albicans PNA FISHAdvanDx, Inc.K092655K062461
C. Albicans screenCarr-Scarborough Microbiologicals, Inc.K891476
T2Candida 1.1 PanelT2 Biosystems, Inc.K173536
Candida glabrata / Candida
species group / Trichomonas vaginalis (TV)
Aptima CV/TV AssayCandida glabrata / Candida
species group / Trichomonas vaginalis (TV)
K190472
Clostridium difficileARIES C. difficile Complete Kit, ARIES C. difficile Assay Protocol File KitLuminexK171441
Solana C. difficile AssayQuidel CorporationK170491
ICEPlex C. difficile KitPrimeraDxK132726
IMDx C. difficile for Abbott m2000Intelligent Medical Devices, Inc.K132235
BD Diagnostics BD MAX Cdiff AssayGeneOhm Sciences Canada Inc.K130470
Quidel Molecular Direct C. difficile AssayQuidel CorporationK123998
Verigene C. Difficile Nucleic acid TestNanosphere, Inc.K123197
Portrait Toxigenic C. difficile AssayGreat Basin Scientific, Inc.K113358
Simplexa C. difficile Universal Direct AssayFocus Diagnostics, Inc.K113433K163085K163085/S001
Xpert C. difficile/EpiCepheidK110203
Illumigene C. difficile DNA Amplification AssayMeridian Bioscience, Inc.K110012
Illumigene C. difficile AssayMeridian Bioscience, Inc.K100818K110012
Xpert C. difficileCepheidK091109
ProGastro Cd AssayProdesse Inc.K090239
BD GeneOhm C. diff AssayBD Diagnostics/ GeneOhm Sciences, Inc.K081920
ARTUS C. DIFFICILE QS-RGQ MDX KITQIAGEN, GMBHK133936
AMPLIVUE C. DIFFICILE ASSAYQUIDEL CORPORATIONK123355
GenePOC CDiffGenePOC IncK172569
Cobas Cdiff Nucleic Acid Test For Use On The Cobas Liat SystemRoche Molecular Systems, Inc.K171770
Clostridium difficile QC materialCepheid Xpert C. Difficile/Epi Control PanelMicrobiologics, Inc.K190463
Coxiella burnetiiJoint Biological Agent Identification and Diagnostic System (JBAIDS) Q Fever Detection KitIdaho Technology, Inc.K103207
Chlamydia trachomatis / Neisseria gonorrhoeaeAbbott RealTime CT/NG and Multi-Collect Specimen Collection KitAbbott Molecular Inc.K092704K080739
Accuprobe Neisseria gonorrhoeae Culture Confirmation TestGen-Probe, Inc.K895583
Amplicor Chlamydia trachomatis TestRoche Molecular Systems, Inc.K922906
AMPLICOR CT/NG Test for Chlamydia trachomatisRoche Molecular Systems, Inc.K973707
AMPLICOR CT/NG test for Chlamydia trachomatisRoche Diagnostics Corp.K070174
AMPLICOR CT/NG test for Neisseria gonorrhoeaeRoche Diagnostics Corp.K070172
APTIMA Combo 2 AssayGen-Probe, Inc.K111409
APTIMA Combo 2 Assay (Panther System)Hologic/Gen-Probe, Inc.K132251
BD MAX CT/GC/TV, BD MAX InstrumentBecton, Dickinson, & Co.K151589K151589/S001, K151589/S002
BD ProbeTec Chlamydia trachomatis (CT) Qx Amplified DNA AssayBecton, Dickinson, & Co.K091724K090824K081824
BD Probetec Neisseria gonorrhoeae (GC) Qx Amplified DNA AssayBecton, Dickinson, & Co.K091730K090971K090827K081825
BD ProbeTec Chlamydia trachomatis (CT) Qx Amplified DNA Assay on the BD Viper LT SystemBecton, Dickinson, & Co.K140446
BD Probetec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay on the BD Viper LT SystemBecton, Dickinson, & Co.K140048
BDProbeTec ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA AssaysBecton Dickinson Microbiology SystemsK984631
BDProbeTec ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA AssaysBecton, Dickinson, & Co.K012351
binx health io CT/NG Assaybinx health, Inc.K191352
COBAS 4800 CT/NG TestRoche Molecular Systems, Inc.K110923
COBAS AMPLICOR CT/NG test for Chlamydia trachomatisRoche Molecular Systems, Inc.K973718
COBAS AMPLICOR CT/NG test for Chlamydia trachomatisRoche Diagnostics Corp.K053287
COBAS AMPLICOR CT/NG test for Neisseria gonorrhoeaeRoche Molecular Systems, Inc.K974342
COBAS AMPLICOR CT/NG test for Neisseria gonorrhoeaeRoche Diagnostics Corp.K053289
COBAS CT/NG FOR USE ON COBAS 6800/8800 SYSTEMSRoche Molecular Systems, Inc.K173887
cobas CT/NG v2.0 TestRoche Molecular Systems, Inc.K132270K140887K163184
GEN-PROBE AMPLIFIED Chlamydia trachomatis Assay KitGen-Probe, Inc.K962217
GEN-PROBE APTIMA Assay for Neisseria gonorrhoeaeGen-Probe, Inc.K063664K062440K043144
GEN-PROBE APTIMA Assay for Chlamydia trachomatisGen-Probe, Inc.K063451K053446K043072
GEN-PROBE APTIMA Combo 2 AssayGen-Probe, Inc.K043224K032554K003395
GEN-PROBE PACE 2C System for Chlamydia trachomatis and Neisseria gonorrhoeaeGen-Probe, Inc.K940979
GONOSPOT DNA Probe Culture Confirmation TestOrtho Diagnostic Systems, Inc.K872628
GONOSTAT Gonococcal Detection KitSierra Diagnostics, Inc.K991268
Hybrid Capture II CT/GC TestDigene Corp.K981567K010891
Hybrid Capture II CT-ID TestDigene Corp.K990023K010892
Hybrid Capture II GC-ID TestDigene Corp.K981485K010893
LCx Chlamydia trachomatis AssayAbbott LaboratoriesK934622
LCx Neisseria gonorrhoeae AssayAbbott LaboratoriesK935833
PACE 2 Chlamydia trachomatis probe confirmation assayGen-Probe, Inc.K920302
PACE 2 Neisseria gonorrhoeae probe confirmation assayGen-Probe, Inc.K920301
PACE 2 System for Chlamydia trachomatisGen-Probe, Inc.K920378
GEN-PROBE PACE System for Chlamydia trachomatisGen-Probe, Inc.K874878
GEN-PROBE System for Neisseria gonorrhoeae Gen-Probe, Inc.K874620
PACE System for Neisseria gonorrhoeaeGen-Probe, Inc.K881277
Rapid Diagnostic System for Chlamydia trachomatisGen-Probe, Inc.K871878
Roche AMPLICOR CT/NG test for Neisseria gonorrhoeaeRoche Molecular Systems, Inc.K974503
Roche COBAS AMPLICOR Chlamydia trachomatis testRoche Molecular Systems, Inc.K964507
TIGRIS DTS Automated Analyzer APTIMA Assay for Chlamydia trachomatisGen-Probe, Inc.K061413
TIGRIS DTS GEN-PROBE APTIMA Assay for Neisseria gonorrhoeaeGen-Probe, Inc.K061509
TIGRIS DTS GEN-PROBE APTIMA COMBO 2 AssayGen-Probe, Inc.K060652
Xpert CT/NGCepheidK121710
Xpert CT/NGCepheidK190441
 Aptima Combo 2 Assay (Panther System)Hologic, Inc.K190515
Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), Trichomonas vaginalis (TV)BD MAX CTGCTV2 (assay); BD MAX (instrument)Becton, Dickinson & Co. (BD)K182692
CT/GC/TV QC materialBD MAX CT/GC/TV 20-DAY QC PANELMICROBIOLOGICS, INC.K181683
CT/GC QC materialCepheid Xpert CT/NG Control PanelMicrobiologics, Inc.K190223
CytomegalovirusAbbott RealTime CMVAbbott MolecularP160044
ARTUS CMV RGQ MDX KitQIAGENP130027 S001-S002
COBAS CMV TestRoche Molecular SystemsP160041 S001
COBAS AmpliPrep/COBAS TaqMan CMV TestRoche Molecular SystemsP110037 S001-S031
NucliSens CMV pp67Organon Teknika CorporationK983762
Dengue virusCDC DENV-1-4 Real-Time RT-PCR AssayCenters for Disease Control and PreventionK113336
EntercoccusIMDx Van R for Abbott m2000Intelligent Medical Devices, Inc.K123753
BD GeneOhm VanR AssayBD Diagnostics (GeneOhm Sciences, Inc.)K102416
Xpert vanA AssayCepheidK092953
E. faecalis/OE PNAAdvanDx, Inc.K083074
GBS PNA FISHAdvanDx, Inc.K082612
E. faecalis PNA FISH culture identification kitAdvanDx, Inc.K063127
Enteric parasite QC materialBD MAX ENTERIC PARASITE CONTROL PANEL, BD MAX ENTERIC PARASITE 20-DAY QC PANELMICROBIOLOGICS, INC.K181711
EnterovirusNucliSens EasyQ Enterovirus vl.1 AssaybioMérieux, Inc.K093383K063261
Escherichia coli / Klebsiella pneumoniae / Pseudomonas aeroginosaGNR Traffic Light PNA FISHAdvanDx, Inc.K101558
E. coli/P. aeruginosa PNA FISHAdvanDx, Inc.K092236K081309
EK/P aeruginosa PNA FISHAdvanDx, Inc.K092393K081433
E. coli PNA FISHAdvanDx, Inc.K082068
Francisella tularensisJBAIDS Tularemia Detection KitIdaho Technology, Inc.K072547
Fungal Pathogen PanelEPLEX BLOOD CULTURE IDENTIFICATION PANEL FUNGAL PATHOGEN (BCID-FP) PANELGENMARK DIAGNOSTICS, INCORPORATEDK182690
Gram-Positive / Gram-Negative BacteriaAccelerate Pheno System, Acceleraet Phenotest BC KitAccelerate DiagnosticsDEN160032DEN160032/S001
Great Basin Staph ID/R Blood Culture PanelGreat Basin Scientific, Inc.K152470K152470/S001
hemoFISH MasterpanelMiacom Diagnostics GMBHK150031K150031/S001
IC-GPC Assay for use on the IC-System (positive blood cultures)iCubate, Inc.K163390K163390/S001
Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP)Nanosphere, Inc.K122514K113450
Xpert Carba-R (GNR)CepheidK152614K152614/S001, K160901 (Rectal Swabs)
EPLEX BLOOD CULTURE IDENTIFICATION PANEL – GRAM POSITIVE (BCID-GP) PANELGENMARK DIAGNOSTICS, INCORPORATEDK181663
EPlex Blood Culture Identification Gram Negative (BCID-GN) PanelGenMark Diagnostics, IncorporatedK182619
IC-GN IC-Cassette For Use On The IC-SystemICubate, Inc.K190341
Gram-Positive / Gram-Negative Bacteria (Antimicrobial resistance)XPERT CARBA-RCEPHEIDK173263
Herpes Simplex VirusAptima Herpes Simpex Viruses 1 & 2Hologic, Inc.K162673K162673/S001
ARIES HSV 1&2 Assay Cassettes – Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit Luminex CorporationK151906
ARIES SystemLuminex CorporationK160517K160517/S001
ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD)Luminex CorporationK161495
IsoAmp HSV AssayBioHelix CorporationK111951
MultiCode-RTx Herpes Simplex Virus 1 & 2 KitEraGen Biosciences, Inc.K111527K100336
BD ProbeTec Herpes Simplex Viruses (HSV I & 2) QX Amplified DNA AssaysBD Diagnostic SystemsK103798
SIMPLEXA HSV 1&2 DIRECTFOCUS DIAGNOSTICSK133621 (DEN130049)
AMIPLIVUE HSV 1&2 ASSAYQUIDEL CORPORATIONK140029
IMDX HSV-1/2 FOR ABBOTT M2000INTELLIGENT MEDICAL, INC.K140198
SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACKFOCUS DIAGNOSTICSK141458K151565K151565/S001
SIMPLEXA HSV 1 & 2 DIRECT, SIMPLEXA HSV 1 & 2 Positive Control PackDIASORIN MOLECULAR LLCK173798
Solana HSV 1+2/VZV AssayQuidel CorporationK162451
ARTUS HSV-1/2 QS-RGQ MDx KITQIAGENK142738
SEEGENE ANYPLEX II HSV-1/2 ASSAYSEEGENEK142156
QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAYDIAGNOSTIC HYBRIDS INC.K133448 (DEN140004)
SENTOSA SA201 HSV 1/2 QUALITATIVE PCR TESTVELA DIAGNOSTICS USA INC.K172509
HSV 1 & 2 ELITE MGB KIT; ELITE INGENIUSELITECHGROUPK180559
Hepatitis virusAbbott RealTime HCV Genotype IIAbbott Molecular, Inc.P120012 S001-S0016
Abbott Realtime HCV AssayAbbott Molecular, Inc.P100017 S001-S006, S007-S012, S014-S019
Abbott Realtime HBV AssayAbbott Molecular, Inc.P080026 S001-S004, S005-S014, S016-S020
Aptima HCV Quant Dx AssayHologic, Inc.P160023
COBAS HBV TestRoche Molecular SystemsP150014 S001-S008
COBAS HCV TestRoche Molecular SystemsP160016
COBAS HCV TestRoche Molecular SystemsP150015 S001-S007
COBAS AmpliPrep/COBAS TaqMan HCV testRoche Molecular SystemsP060030 S001-S032, S033-S047, S048-S058
COBAS Taqman HBV TestRoche Molecular Systems, Inc.P050028 S001-S027, S028-S047, S048, S050-S057
Versant HCV 3.0 Assay (bDNA)Siemens Healthcare DiagnosticsP020022
Versant HCV RNA Qualitative AssayGen-Probe, Inc.P020011 S001-S007, S008, S009
COBAS AMPLICOR Hepatitis C Virus (HCV) TestRoche Molecular Systems, Inc.P000012 S001-S043, S044-S053, S054-S056
AMPLICOR HCV Test, v2.0Roche Molecular Systems, Inc.P000010 S001-S024
APTIMA HBV QUANT ASSAYHOLOGIC, INCP170025
Human MetapneumovirusPro hMPV+ AssayGen-Probe Prodesse, Inc.K132200K082688K123838
Quidel Molecular hMPV AssayQuidel CorporationK112490
Quidel Molecular RSV + hMPV AssayQuidel CorporationK131813K122189
Human papillomavirusAPTIMA HPV 16 18/45 Genotype AssayGen-Probe, Inc.P120007 S001-S010
APTIMA HPV AssayGen-Probe, Inc.P100042 S001-S012
Cervista HPV 16/18Hologic, Inc.P080015 S001-S012
Cervista HPV HR and Genfind DNA Extraction KitHologic, Inc.P080014 S001-S018
COBAS HPV TestRoche Molecular Systems, Inc.P100020 S001-S024
Digene Hybrid Capture 2 High-Risk HPV DNA TestDigene CorporationP890064 S001-S034
BD ONCLARITY HPV ASSAYBECTON, DICKINSON AND COMPANYP160037
Influenza and Respiratory VirusesPLEX-ID Flu assayAbbott LaboratoriesK121003
Alere i Influenza A & BALERE SCARBOROUGH, INC D/B/A BINAX, INCK141520K151464K151690K163266
Alere i RSVAlere Scarborough, Inc.K161375
ARIES Flu A/B & RSV AssayLuminex CorporationK161220
artus Infl A/B RG RT-PCR KitQiagen GmbHK113323
CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization PanelCenters for Disease Control and PreventionK080570
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and PreventionK133869K132508K130551K123905K111507K161556
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping KitCenters for Disease Control and PreventionK161556
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A/B Typing KitCenters for Disease Control and PreventionK172091
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL INFLUENZA A/H5 SUBTYPINGCENTERS FOR DISEASE CONTROL AND PREVENTIONK141859K153148
CDC Influenza 2009 A (H1N1) pdm Real-Time RT-PCR PanelCenters for Disease Control and PreventionK101564
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel Influenza B Lineage Genotyping KitCenters for Disease Control and PreventionK181736
XPERT XPRESS FLU/RSV, XPERT Nasopharyngral Sample Collection Kit, XPERT Nasal Sample Collection Kit, GENEXPERT XPRESS II, GENEXPERT XPRESS IVCepheidK180218
ACCULA RSV TESTMESA BIOTECH, INC.K181443
BioCode Respiratory Pathogen Panel (RPP)Applied BioCode, IncK192485
cobas Liat Influenza A/B & RSVIquum, Inc.K153544K153544/S001
ePlex Respiratory Pathogen PanelGenMark Diagnostics, IncK163636K163636/S001
eSensor Respiratory Viral Panel (RVP)Clinical Micro Sensors, Inc.K113731
FilmArray Respiratory Panel (RP)Idaho Technology, Inc.K120267K110764K103175
FilmArray Respiratory Panel (RP)BioFire Diagnostics, LLCK123620K143080K160068
FilmArray Respiratory Panel 2 (RP2)BioFire Diagnostics, LLCK170604
FilmArray Respiratory Panel EZ (RP EZ)BioFire Diagnostics, LLCK152579K152579/S001, K152579/S002
FilmArray RP EZ Control Panel M265Maine Molecular Quality Controls, Inc.K161573
Idylla Respiratory (IFV-RSV) PanelJanssen Pharmaceutica NVK163628K163629K163630
IMDx Flu A/B and RSV for Abbott m2000Intelligent Medical Devices, Inc.K131584
INFLUENZA A SUBTYPING KIT CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELCENTERS FOR DISEASE CONTROL AND PREVENTIONK140851
Influenza A/H5 (Asian lineage) Virus Real-time RT-PCR Primer and Probe SetCenters for Disease Control and PreventionK060159
INFLUENZA B LINEAGE GENOTYPING KIT CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELCENTERS FOR DISEASE CONTROL AND PREVENTIONK140857
JBAIDS Influenza A Subtyping KitU.S. Army Medical Materiel Development ActivityK111778
JBAIDS Influenza A&B Detection KitU.S. Army Medical Materiel Development ActivityK111775K152523
JBAIDS Influenza A/H5 (Asian lineage) Detection KitU.S. Army Medical Materiel Development ActivityK100287
Liat Influenza A/B AssayIQuum, Inc.K111387
LYRA PARAINFLUENZA VIRUS ASSAYQUIDEL CORPORATIONK141927
NxTAG Respiratory Pathogen PanelLuminex Molecular Diagnostics, Inc.K152386K152386/S001
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT SoftwareLuminex Molecular Diagnostics, Inc.K193167
Prodesse ProFAST AssayGen-Probe Prodesse, Inc.K132237
Prodesse ProFlu + AssayGen-Probe Prodesse, Inc.K132129
Prodesse ProParaflu AssayGen-Probe Prodesse, Inc.K132238K091053
Prodesse ProParaflu AssayHologic/Gen-Probe Prodesse, Inc.K153223K132238
ProFlu+ AssayHologic/Gen-Probe Prodesse, Inc.K153219K110968K092500K081030K073029
ProParaFlu + AssayProdesse, Inc.K091053
Quidel Molecular Influenza A + B AssayQuidel CorporationK131728K113777K112172
Simplexa Flu A/B & RSVFocus Diagnostics, Inc.K102170
Simplexa Flu A/B & RSV DirectFocus Diagnostics, Inc.K120413K142365K152408
Simplexa Influenza A H1N1 (2009)Focus Diagnostics, Inc .K100148
Solana Influenza A+B AssayQuidel CorporationK161814
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)Nanosphere, Inc.K143653K143653/S001
Verigene Respiratory Virus Plus Nucleic Acid Test (RV+)Nanosphere, Inc.K103209K093337K092957K092566K083088
Xpert Xpress FluCepheidK162456K162456/S001, K171552
Xpert Flu + RSV XpressCepheidK151226K162331K162331/S001
Xpert Flu AssayCepheidK123191K120911K103766
XPERT FLU/RSV XC ASSAYCepheidK142045
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 SYSTEMCepheidK181289
xTAG Respiratory Viral Panel (RVP)Luminex Molecular Diagnostics, Inc.K112781K112199K091667K081483K063765
xTAG Respiratory Viral Panel Fast (RVP FAST)Luminex Molecular Diagnostics, Inc.K103776
ACCULA FLU A/FLU B TESTMESA BIOTECH, INC.K171641
Alere I Influenza A & B 2, Alere I Instrument, Alere I Influenza A & B Control Swab KitAlere Scarborough, Inc.K171792
FilmArray RP2/RP2plus Control PanelMaine Molecular Quality Controls, Inc.K173171
FILMARRAY RESPIRATORY PANEL 2 PLUS (RP2PLUS)BIOFIRE DIAGNOSTICS, LLCDEN170017
Panther Fusion AdV/HMPV/RV AssayHologic, Inc.K172629
Panther Fusion Paraflu AssayHologic, Inc.K172282
Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, PantherHologic, Inc.K171963
Solana RSV+HMPV AssayQuidel CorporationK171974
ID NOW Influenza A & B 2Alere Scarborough, Inc.K190204
ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.K191534
Cobas Influenza A/B Nucleic Acid Test For Use On The Cobas Liat SystemRoche Molecular Systems, IncK191729
FluChip-8G Influenza A+B AssayInDevR, IncK182513
Cdc Human Influenza Virus Real-Time Rt-Pcr Diagnostic Panel, Influenza A/B Typing Kit, Cdc Human Influenza Virus Real-Time Rt-Pcr Diagnostic Panel, Influenza A Subtyping Kit, Cdc Human Influenza Virus Real-Time Rt-Pcr, Influenza B Lineage Genotyping Kit, Cdc Human Influenza Virus Real-Time Rt-Pcr,Centers For Disease Control And PreventionK190302
Influenza and Respiratory Viruses
Influenza A & B, Strep A, RSV
ALERE I INFLUENZA A & B, ALERE I STREP A, ALERE I RSV, ALERE I INFLUENZA A & B 2Alere Scarborough, Inc.K173932
ALERE I INFLUENZA A & B, ALERE I STREP A, ALERE I RSV, ALERE I INFLUENZA A & B 4Alere Scarborough, Inc.K173932
ALERE I STREP A 2, ALERE I INSTRUMENT, ALERE I STREP A 2 CONTROL SWAB KITAlere Scarborough, Inc.K173653
Respiratory panel control materialCepheid Xpert Respiratory Control PanelMicrobiologics, Inc.K190086
Respiratory panelQIAstat-Dx Respiratory Panel; QIAstat-Dx AnalyzerQIAGEN GmbH 
LeishmaniaspeciesSMART LeishU.S. Army Medical Materiel Development ActivityK081868
Meningitis/EncephalitisFilmArray Meningitis/Encephalitis(ME) PanelBioFire Diagnostics LLCDEN150013DEN150013/S001, K160462
Mycobacterium tuberculosisXpert MTB/RIF AssayCepheidK131706
BDProbetec ET Mycobacterium tuberculosis complex culture identification kitBecton, Dickinson, & Co.K000884
Amplified Mycobacterium tuberculosis Direct TestGen-Probe, Inc.P940034
Amplicor Mycobacterium tuberculosis testRoche Molecular Systems, Inc.P940040
SNAP M.tuberculosis complexSyngene, Inc.K900292
Accuprobe Mycobacterium tuberculosis complex TestGen-Probe, Inc.K896493
Rapid Diagnostic System for Mycobacterium tuberculosisGen-Probe, Inc.K871795
Rapid Identification Test for Mycobacterium tuberculosis complexGen-Probe, Inc.K862614
Mycobacterium speciesAccuprobe Mycobacterium avium complex cultureGen-Probe, Inc.K921435K896494K897078
Accuprobe Mycobacterium kansasii Identification TestGen-Probe, Inc.K904463
SNAP Mycobacterium avium complexSyngene, Inc.K900202
Accuprobe Mycobacterium intracellulare Culture Identification TestGen-Probe, Inc.K897077
Accuprobe Mycobacterium gordonae culture identification TestGen-Probe, Inc.K896492
Rapid Diagnostic System for Mycobacterium gordonaeGen-Probe, Inc.K890089
Rapid Diagnostic System for MycobacteriaGen-Probe, Inc.K864597
Rapid Identification Test for Mycobacterium aviumGen-Probe, Inc.K862613
Gen-Probe Mycobacterium Rapid Confirmation SystemGen-Probe, Inc.K860782
Mycoplasma GenitaliumAptima Mycoplasma Genitalium AssayHologic, Inc.DEN180047
Mycoplasma genitalium (MG)  and Trichomonas vaginalis (TV)Cobas TV/MG For Use On Cobas 6800/8800 Systems, Cobas TV/MG Positive Control Kit, Cobas Buffer Negative Control KitRoche Molecular Systems, Inc.K190433
Mycoplasma pneumoniaeillumigene Mycoplasma Direct DNA Amplification AssayMeridian Bioscience, Inc.K160829
illumigene Mycoplasma DNA Amplification AssayMeridian Bioscience, Inc.K152800K123423
Multiplex PanelBD Max Vaginal Panel, BD MAX InstrumentGeneOhm Sciences CanadaDEN160001DEN160001/S001
BIOCODE GASTROINTESTINAL PATHOGEN PANEL (GPP)APPLIED BIOCODE, INC.K180041
Curetis Unyvero LRT ApplicationCuretis GmbHDEN170047
Unyvero LRT BAL ApplicationCuretis GmbHK191967
ePlex instrument (multiplex)GenMark Diagnostics, IncK163652K163652/S001
FilmArray BCID PanelBioFire Defense, LLCK143171K160457
FilmArray NGDS Warrior PanelBioFire Defense, LLCK170883DEN160048
FilmArray Warrior Control PanelMaine Molecular Quality Controls, Inc.K163522
NEUMODX GBS ASSAYNEUMODX MOLECULAR, INC.K173725
PANNAT STEC TESTMICRONICS, INCK173330
ProGastro SSCS AssayGen-Probe Prodesse, Inc.K123274
Biocode Gastrointestinal Pathogen Panel (GPP)Applied Biocode, Inc.K190585
EntericBio Dx AssaySerosep, Ltd.K182703
xTAG Gastrointestinal Pathogen Panel (GPP)Luminex Molecular Diagnostics, Inc.K121894K121454
BD MAX Extended Enteric Bacterial Panel, BD MAX SystemBecton Dickinson and CompanyK170308
BD MAX ENTERIC VIRAL PANEL, BD MAX INSTRUMENTBecton Dickinson and CompanyK181427
FILMARRAY GASTROINTESTINAL (GI) PANELBIOFIRE DIAGNOSTICSK140407K160459K160459/S001
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)Luminex Molecular Diagnostics, Inc.K191160
xTAG Gastrointestinal Pathogen Panel (GPP)Luminex Molecular Diagnostics, Inc.K191161
Luminex Molecular Diagnostics, Inc.K191160
T2BACTERIA PANELT2 BIOSYSTEMS, INC.K172708
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)Luminex Molecular Diagnostics, Inc.K191160
xTAG Gastrointestinal Pathogen Panel (GPP)Luminex Molecular Diagnostics, Inc.K191161
Great Basin Stool Bacterial Pathogens PanelGreat Basin Scientific, Inc.K163571K163571/S001
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSISLUMINEX MOLECULAR DIAGNOSTICS INC.K140377K140647
VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP)NANOSPHERE, INCK140083K142033
FILMARRAY PNEUMONIA PANELBioFire Diagnostics, LLCK180966
FILMARRAY PNEUMONIA PANEL PLUSBioFire Diagnostics, LLCK181324
Multiplex Panel (Pneumonia) QC MaterialFilmArray Pneumonia/Pneumoniaplus ControlMaine Molecular Quality Controls, Inc. (MMQCI)K190222
Non-Variola OrthopoxvirusNON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SETCenters for Disease Control and PreventionK181205
NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SETCenters for Disease Control and PreventionDEN070001
NorovirusRIDA GENE Nororvirus GI/GIIR-Biopharm ABK171511
XPERT NOROVIRUS GENEXPERT Dx SYSTEMS (GX-I GX-11 GX-IV GX-XVI)  GENEXPERT INFINITY-48 SYSTEM, GENEXPERT INFINITY-48S SYSTEM, GENEXPERT INFINITY-80 SYSTEMCEPHEIDK142501
PlasmodiumID-FISH Plasmodium Genus Test Kit, ID-FISh P. falciparum and P. vivax Combo TestID-FISH Technology, Inc.DEN160025DEN160025/S001
RickettsiaRickettsia Real-time PCR AssayCenters for Disease Control and PreventionK170940
SepsisSeptiCyte LABImmunexpress, Inc.K163260
StaphylococcusBD Max MRSA AssayBD Diagnostics (GeneOhm Sciences Canada, Inc.)K120138
Staphylococcus QuickFISH BCAdvanDx, Inc.K113371
MRSA/SA ELITe MGBEliTechGroup Epoch Biosciences.K112937K132468
Verigene Staphylococcus Blood Culture (BC-S) Nucleic Acid TestNanosphere, Inc.K112424
NucliSENS EasyQ MRSA AssaybioMerieux, Inc.K102740
Xpert MRSA/SA Blood Culture AssayCepheidK101879K082140
Xpert MRSA/SA Nasal Complete AssayCepheidK100822
LightCycler MRSA Advanced TestRoche Molecular Systems, IncK091409
BD GeneOhm MRSA ACP AssayBD Diagnostics (GeneOhm Sciences Canada, Inc.)K093346
S. aureus and/or other Staphylococcus species PNA FISH CultureAdvanDx, Inc.K092166
Xpert MRSA/SA SSTI AssayCepheidK080837
BD GeneOhM StaphSR AssayBD Diagnostics (GeneOhm Sciences Canada, Inc.)K071026
S. aureus PNA FISHAdvanDx, Inc.K091827K060099
Xpert MRSACepheidK070462
IDI-MRSA AssayInfectio Diagnostic, Inc.K042357K033415
MECA XPRESSFISHADVANDX INC.K140619
COBAS MRSA/SA TESTROCHE MOLECULAR SYSTEMS INC.K142721
Xpert MRSA NxGCepheidK162444
Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 SystemCepheidK190771
Staphylococcus / MRSA Control MaterialCepheid Xpert MRSA NxG Control PanelMicrobiologics, Inc.K191172
Cepheid Xpert SA Nasal Complete Control PanelMicrobiologics, Inc.K191168
StreptococciARIES GBS AssayLuminex CorporationK162772
Xpert GBS LB AssayCepheidK121539
illumigene Group A Streptococcus (GBS) DNA Amplification AssayMeridian Bioscience, Inc.K122019
illumigene Group B Streptococcus (GBS) DNA Amplification AssayMeridian Bioscience, Inc.K121044
BD Max GBS AssayBecton, Dickinson, & Co.K111860
Cepheid Smart GBS AssayCepheidK062948
Xpert GBSCepheidK060540
IDI-Strep B AssayInfectio Diagnostic, Inc.K022504
Gen-Probe Accuprobe Group B Streptococcus culture identification kitChugai Pharmaceuticals Co, Ltd.K974572
Accuprobe Streptococcus pneumoniae culture confirmationGen-Probe, Inc.K902908
ILLUMIGENE GROUP B STREPTOCOCCUS (GBS) DNA AMPLIFICATION ASSAYMERIDIAN BIOSCIENCE, INC.K112125
AMPLIVUE GBS ASSAYQUIDEL CORPORATIONK133503
LYRA DIRECT STREP ASSAYQUIDEL CORPORATIONK133883 (DEN140005)
AMPLIVUE GAS ASSAYQUIDEL CORPORATIONK141173
LIAT STREP A ASSAYIQUUM INCK141338
revogeneGenePOC Inc.K170558
GenePOC GBS LBGenePOC Inc.K170557
Solana Strep Complete AssayQuidel CorporationK162274
ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File KitLuminex CorporationK172402
Xpert Xpress Strep ACepheidK172126K173398
GenePOC Strep AGenePOC Inc.K183366
Streptococci / GBS Conrol MaterialCepheid Xpert GBS LB Control PanelMicrobiologics, Inc.K182472
Shiga ToxinGreat Basin Shiga Toxin Direct TestGreat Basin Scientific, Inc.K152955K152955/S001, K152955/S002
Trichomonas vaginalisAffirm VP Microbial Identification Test for Gardnerella vaginalis and Trichomonas vaginalisMicroprobe Corp.K923133
Amplivue Trichomonas AssayQuidel CorporationK143329
APTIMA Trichomonas vaginalis (ATV) AssayGen-Probe, Inc.K102911
APTIMA Trichomonas vaginalis Assay (PANTHER System)Gen-Probe, Inc.K122062
BD ProbeTec Trichomonas vaginalis  (TV) QX Amplified DNA AssayBecton, Dickinson & Co.K130268
Solana Trichomonas AssayQuidel CorporationK161182K161182/S001
Xpert TVCepheidK151565K151565/S001, K161619
Transport MediaPRIMESTORE MTMLonghorn Vaccines and Diagnostics LLCDEN170029
Vaginal Panel (Bacterial vaginosis vaginitis)BD MAX Vaginal PanelGeneOhm Sciences Canada, Inc. (BD Diagnostics)DEN160001
Varicella-zoster virusesSimplexa VZV Direct, Simplexa VZV Positive Control PackDiaSorinK192376
Variola Variola Virus Real-Time PCR AssayCenters for Disease Control and PreventionDEN160016DEN160016/S001
Yersinia pestisJBAIDS Plague Detection Kit

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