Medical Devices

Nucleic Acid Based Tests

This is a list of nucleic acid-based tests that have been cleared or approved by the Center for Devices and Radiological Health. These tests analyze variations in the sequence, structure, or expression of deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) in order to diagnose disease or medical conditions, infection with an identifiable pathogen, or determine genetic carrier status.

This list includes nucleic acid-based companion diagnostic tests. A full list of FDA cleared or approved companion diagnostic devices is maintained on a separate page at In Vitro Companion Diagnostic Devices.

List of Human Genetic Tests

Disease/UseTrade NameManufacturerSubmission
Acute Myeloid LeukemiaVysis D7S486/CEP 7 FISH Probe KitAbbott Molecular Inc.K131508
Vysis EGR1 FISH Probe KitAbbott Molecular Inc.K123951,K091960
LeukoStrat CDx FLT3 Mutation AssayINVIVOSCRIBE TECHNOLOGIES, INCP160040
Abbott RealTime IDH2ABBOTT MOLECULAR, INC.P170005
Acute Myeloid Leukemia or Myelodysplastic SyndromeVYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATIONABBOTT MOLECULAR, INC.DEN130010
Aggressive Systemic MastocytosiKIT D816V ASSAYARUP LABARATORIESH140006
Autosomal Recessive Carrier Screening23ANDME PERSONAL GENOME SERVICE23andMeDEN140044
B-cell chronic lymphocytic leukemiaVYSIS CLL FISH PROBE KITABBOTT MOLECULAR, INCK100015
VYSIS CLL FISH PROBE KITABBOTT MOLECULAR, INCP150041
CEP 12 SpectrumOrange Direct Labeled Chromosome Enumeration DNA ProbeVysisK962873
Bladder CancerVysis UroVysion Bladder Cancer Recurrence KitVysisK033982, K013785, K011031
Breast Cancer23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)23andMeDEN170046
Prosigna Breast Cancer Prognostic Gene Signature AssayNanostring TechnologiesK130010
MammaPrintAgendia BVK101454, K081092, K080252, K070675, K062694
INFORM HER2 Dual ISH DNA Probe CocktailVentana Medical Systems, Inc.P100027
HER2 CISH pharmDxTM KitDako Denmark A/SP100024
GeneSearch Breast Lymph Node (BLN) Test KitVeridex, LLC.P060017 S001-S004
Dako TOP2A FISH PharmDx KitDako Denmark A/SP050045 S001-S004
HER2 IQFISH PHARMDXDAKO DENMARK A/SP040005
INSITE HER-2/NEU KITBIOGENEX LABORATORIES, INC.P040030
SPOT-LIGHT HER2 CISH KITINVITROGEN CORPORATIONP050040
INFORM HER-2/NEUVENTANA MEDICAL SYSTEMS, INC.P940004
DAKO HERCEPTESTDAKO A/SP980018
PATH VYSION HER-2 DNA PROBE KITABBOTT MOLECULAR, INC.P980024
DakoCytomation Her2 FISH pharmDx™ KitDakoCytomation Denmark A/SP040005
Chromosome abnormalitiesAffymetrix CytoScan Dx AssayAffymetrix, Inc.K130313
AneuVysionVysisK010288, K972200
CYTOSCAN(R) DXAffymetrix, Inc.DEN130018
GenetiSure Dx Postnatal AssayAgilent Technologies, Inc.K163367
CEP 8 Spectrumorange DNA Probe KitVysisK953591
CEP X SpectrumOrange/ Y SpectrumGreen DNA Probe KitVysisK954214
Chronic Myeloid LeukemiaQuantidex qPCR BCR-ABL IS KitASURAGEN, INC.DEN160003
MRDx BCR-ABL Test, MRDx BCR-ABL Test SoftwareMolecularMD CorporationK173492
Coagulation FactorsInvader Factor VHologic, Inc.K100980
Invader Factor IIHologic, Inc.K100943
Illumina VeraCode Genotyping Test for Factor V and Factor IIIllumina, Inc.K093129
eSensor Thrombophilia Risk Test, eSensor FII-FV Genotyping Test, eSensor Fll Genotyping Test, eSensor FV Genotyping Test, eSensor MTHFR Genotyping TestOsmetech Molecular DiagnosticsK093974
Xpert HemosIL FII & FVCepheidK082118
Verigene F5 Nucleic Acid Test
Verigene F2 Nucleic Acid Test
Verigene MTHFR Nucleic Acid Test
Nanosphere, Inc.K070597
INFINITI SystemAutogenomics, Inc.K060564
Factor II (Prothrombin) G20210A KitRoche Diagnostics CorporationK033612
Factor V leiden KitRoche Diagnostics CorporationK033607
Invader MTHFR 677Hologic, Inc.K100987
Invader MTHFR 1298Hologic, Inc.K100496
COAGULATION, LATE-ONSET ALHEIMER'S DISEASE, PARKINSON'S DISEASE, CELIAC DISEASE, ALPHA-1 ANTITRYPSIN DEFICIENCY, EARLY-ONSET PRIMARY DYSTONIA, FACTOR IX DEFICIENCY, GAUCHER DISEASE TYPE 1, GLUCOSE-6-PHOPHATE DEHYDROGENASE DEFICIENCY, HERDITARY HEMOCHROMATOSIS, HEREDITARY THROMBOPHILIAPERSONAL GENOME SERVICE (PGS) GENETIC HEALTH RISK TEST FOR HEREDITARY THROMBOPHILIA23andMEDEN160026
Colorectal CancerCologuardExact Sciences CorporationP130017
Therascreen KRAS RGQ PCR KitQIAGEN MANCHESTER LTDP110027/P110030
Epi ProColon®Epigenomics AGP130001
Cobas KRAS MUTATION TESTRoche Molecular Systems, Inc.P140023
Praxis Extended RAS PanelIllumina, Inc.P160038
VENTANA ANTI-MLH-1(M1) MOUSE MONOCLONAL PRIMARY ANTIBODY, VENTANA ANTI-PMS2 (A16-4) MOUSE MONOCLONAL PRIMARY ANTIBODY, VENTANA ANTI-MSH2 (G219-1129) MOUSE MONOCLONAL PRIMARY ANTIBODY, VENTANA ANTI-MSH6 (SP 93) MOUSE MONOCLONAL PRIMARY ANTIBODY, VENTANA ANTI-BRAF V600E (VE1) MOUSE MONOCLONAL PRIMARY ANTIBODYVentana Medical SystemsDEN170030
Cystic FibrosisIllumina MiSeqDx Cystic Fibrosis Clinical Sequencing AssayIllumina, IncK132750
Illumina MiSeqDx Cystic Fibrosis 139-Variant AssayIllumina, IncK124006
xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTRLuminex Molecular Diagnostics, Inc.K163336
xTAG Cystic Fibrosis 39 Kit v2Luminex Molecular Diagnostics, Inc.K163347
eSensor CF Genotyping TestOsmetech Molecular DiagnosticsK090901
xTAG Cystic Fibrosis 60 Kit v2Luminex Molecular Diagnostics Inc.K083845
xTAG Cystic Fibrosis 39 Kit v2Luminex Molecular Diagnostics Inc.K083846
Verigene CFTR and Verigene CFTR PolyT Nucleic Acid TestsNanosphere, IncK083294
InPlex CF Molecular TestThird Wave Technology, Inc.K063787
Cystic Fibrosis Genotyping AssayCelera DiagnosticsK062028
Tag-It Cystic Fibrosis KitTm Bioscience CorporationK060627, K043011
eSensor Cystic Fibrosis Carrier Detection SystemClinical Micro Sensors, Inc.K060543, K051435
Drug metabolizing enzymesxTAG CYP2D6 Kit v3Luminex Molecular Diagnostics, Inc.K130189, K093420
xTAG CYP2D6 Kit v3Luminex Molecular Diagnostics, Inc.K130189, K131565
Spartan RX CYP2C19 Test SystemSpartan Bioscience, Inc.K123891
Verigene CYP2C 19 Nucleic Acid TestNanosphere, Inc.K120466
INFINITI CYP2C19 AssayAutoGenomics, Inc.K101683
Invader UGT1A1 Molecular AssayThird Wave Technologies Inc.K051824
Roche AmpliChip CYP450 microarrayRoche Molecular Systems, Inc.K043576, K042259
eSensor Warfarin Sensitivity Saliva TestGenMark DiagnosticsK110786
eQ-PCR LC Warfarin Genotyping kitTrimGen CorporationK073071
eSensor Warfarin Sensitivity Test and XT-8 InstrumentOsmetech Molecular DiagnosticsK073720
Gentris Rapid Genotyping Assay - CYP2C9 & VKORCIParagonDx, LLCK071867
INFINITI 2C9 & VKORC1 Multiplex Assay for WarfarinAutoGenomics, Inc.K073014
Verigene Warfarin Metabolism Nucleic Acid Test and Verigene SystemNanosphere, Inc.K070804
XTAG CYP2C19 KIT V3LUMINEX MOLECULAR DIAGNOSTICS, INC.K131565
Heart TransplantAlloMap Molecular Expression TestingxDxK073482
HEREDITARY THROMBOPHILIAIMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TESTSEQUENOM, INC./AGENA BioscienceK132978
MelanomaRoche cobas DNA Sample Preparation Kit, COBAS 4800 BRAF V600 MUTATION TESTRoche Molecular Systems, Inc.P110020
THXID-BRAF KITBioMerieux, Inc.P120014
Myelodysplastic syndrome / myeloproliferative diseaseFluorescence in situ hybridization, platelet-derived growth factor receptor, beta polypeptide (pdgfrb), rearrangementARUP LABARATORIESH140005
Myeloproliferative disease / Polycythemia VeraIpsogen JAK2 RGQ PCR KitQIAGEN INCDEN160028
Myeloproliferative disease / Polycythemia VeraIpsogen JAK2 RGQ PCR KitQIAGEN INCK172287
Non-Small Cell Lung CancerVYSIS ALK BREAK APART FISH PROBE KITABBOTT MOLECULAR, INC.P110012
Cobas EGFR MUTATION TEST v2Roche Molecular Systems, Inc.P120019
THERASCREEN EGFR RGQ PCR KITQIAGEN MANCHESTER LTDP120022
Cobas EGFR MUTATION TEST v2Roche Molecular Systems, Inc.P150044
Cobas EGFR MUTATION TEST v2Roche Molecular Systems, Inc.P150047
Oncomine Dx Target TestLIFE TECHNOLOGIES CORPORATIONP160045
Ovarian CancerBRACAnalysis CDxMyriad Genetic Laboratories, Inc.P140020
FoundationFocus CDxBRCAFOUNDATION MEDICINE, INCP160018
Platforms, Imaging Systems, and ReagentsILLUMINA MISEQDX PLATFORMIllumina, IncDEN130011
MISEQDX UNIVERSAL KIT 1.0Illumina, Inc.DEN130042
DUET SYSTEMBIOVIEW LTD.K130775
Prostate CancerNADiA ProsVueIris Molecular DiagnosticsK101185
PROGENSA PCA3 AssayGen-Probe, Inc.P100033
Severe Combined Immunodeficiency Disorder (SCID)PerkinElmer Enlite TREC Test SystemWallac OYDEN140010
Tissue of OriginPathwork Tissue of Origin Test Kit – FFPEPathwork Diagnostics Inc.K120489, K092967
Pathwork Tissue of Origin TestPathwork Diagnostics Inc.K080896
Tissue of Origin Test Kit - FFPECancer Genetics, Inc.K173839
Tumor ProfilingMSK-IMPACT (Integrated Mutation Profiling Of Actionable Cancer Targets):A Hybridization-Capture Based Next Generation Sequencing AssayMemorial Sloan-Kettering Cancer CenterDEN170058

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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
Bacillus AnthracisJBAIDS Anthrax Detection SystemIdaho Technology, Inc.K131930K071188, K051713
BordetellaARIES Bordetella Assay; ARIES Bordetella Assay Protocol File KitLuminex CorporationK163626, K163626/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.K133673, K152285
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
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.K113433, K163085, K163085/S001
Xpert C. difficile/EpiCepheidK110203
Illumigene C. difficile DNA Amplification AssayMeridian Bioscience, Inc.K110012
Illumigene C. difficile AssayMeridian Bioscience, Inc.K100818, K110012
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
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.K151589, K151589/S001, K151589/S002
BD ProbeTec Chlamydia trachomatis (CT) Qx Amplified DNA AssayBecton, Dickinson, & Co.K091724K090824, K081824
BD Probetec Neisseria gonorrhoeae (GC) Qx Amplified DNA AssayBecton, Dickinson, & Co.K091730K090971, K090827K081825
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
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.K132270K140887, K163184
GEN-PROBE AMPLIFIED Chlamydia trachomatis Assay KitGen-Probe, Inc.K962217
GEN-PROBE APTIMA Assay for Neisseria gonorrhoeaeGen-Probe, Inc.K063664K062440, K043144
GEN-PROBE APTIMA Assay for Chlamydia trachomatisGen-Probe, Inc.K063451K053446, K043072
GEN-PROBE APTIMA Combo 2 AssayGen-Probe, Inc.K043224K032554, K003395
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.K981567, K010891
Hybrid Capture II CT-ID TestDigene Corp.K990023, K010892
Hybrid Capture II GC-ID TestDigene Corp.K981485, K010893
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/NGCepheidK173840
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
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
Gram-Positive / Gram-Negative BacteriaAccelerate Pheno System, Acceleraet Phenotest BC KitAccelerate DiagnosticsDEN160032, DEN160032/S001
Great Basin Staph ID/R Blood Culture PanelGreat Basin Scientific, Inc.K152470, K152470/S001
hemoFISH MasterpanelMiacom Diagnostics GMBHK150031, K150031/S001
IC-GPC Assay for use on the IC-System (positive blood cultures)iCubate, Inc.K163390, K163390/S001
Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP)Nanosphere, Inc.K122514K113450
Xpert Carba-R (GNR)CepheidK152614, K152614/S001, K160901 (Rectal Swabs)
Gram-Positive / Gram-Negative Bacteria (Antimicrobial resistance)XPERT CARBA-RCEPHEIDK173263
Herpes Simplex VirusAptima Herpes Simpex Viruses 1 & 2Hologic, Inc.K162673, K162673/S001
ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit Luminex CorporationK151906
ARIES SystemLuminex CorporationK160517, K160517/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 DIAGNOSTICSK141458, K151565, K151565/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
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.K132200K082688, K123838
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, INCK141520, K151464, K151690, K163266
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 PreventionK133869K132508, K130551K123905, K111507, K161556
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 PREVENTIONK141859, K153148
CDC Influenza 2009 A (H1N1) pdm Real-Time RT-PCR PanelCenters for Disease Control and PreventionK101564
cobas Liat Influenza A/B & RSVIquum, Inc.K153544, K153544/S001
ePlex Respiratory Pathogen PanelGenMark Diagnostics, IncK163636, K163636/S001
eSensor Respiratory Viral Panel (RVP)Clinical Micro Sensors, Inc.K113731
FilmArray Respiratory Panel (RP)Idaho Technology, Inc.K120267, K110764K103175
FilmArray Respiratory Panel (RP)BioFire Diagnostics, LLCK123620, K143080, K160068
FilmArray Respiratory Panel 2 (RP2)BioFire Diagnostics, LLCK170604
FilmArray Respiratory Panel EZ (RP EZ)BioFire Diagnostics, LLCK152579, K152579/S001, K152579/S002
FilmArray RP EZ Control Panel M265Maine Molecular Quality Controls, Inc.K161573
Idylla Respiratory (IFV-RSV) PanelJanssen Pharmaceutica NVK163628, K163629, K163630
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 ActivityK111775, K152523
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.K152386, K152386/S001
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.K153223, K132238
ProFlu+ AssayHologic/Gen-Probe Prodesse, Inc.K153219, K110968, K092500K081030, K073029
ProParaFlu + AssayProdesse, Inc.K091053
Quidel Molecular Influenza A + B AssayQuidel CorporationK131728K113777, K112172
Simplexa Flu A/B & RSVFocus Diagnostics, Inc.K102170
Simplexa Flu A/B & RSV DirectFocus Diagnostics, Inc.K120413, K142365, K152408
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.K143653, K143653/S001
Verigene Respiratory Virus Plus Nucleic Acid Test (RV+)Nanosphere, Inc.K103209K093337, K092957K092566, K083088
Xpert Xpress FluCepheidK162456, K162456/S001, K171552
Xpert Flu + RSV XpressCepheidK151226, K162331, K162331/S001
Xpert Flu AssayCepheidK123191K120911, K103766
XPERT FLU/RSV XC ASSAYCepheidK142045
xTAG Respiratory Viral Panel (RVP)Luminex Molecular Diagnostics, Inc.K112781K112199, K091667K081483, K063765
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
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
LeishmaniaspeciesSMART LeishU.S. Army Medical Materiel Development ActivityK081868
Meningitis/EncephalitisFilmArray Meningitis/Encephalitis(ME) PanelBioFire Diagnostics LLCDEN150013, DEN150013/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.K921435K896494, K897078
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 pneumoniaeillumigene Mycoplasma Direct DNA Amplification AssayMeridian Bioscience, Inc.K160829
illumigene Mycoplasma DNA Amplification AssayMeridian Bioscience, Inc.K152800, K123423
Multiplex PanelBD Max Vaginal Panel, BD MAX InstrumentGeneOhm Sciences CanadaDEN160001/ DEN160001/S001
ePlex instrument (multiplex)GenMark Diagnostics, IncK163652, K163652/S001
FilmArray BCID PanelBioFire Defense, LLCK143171, K160457
FilmArray NGDS Warrior PanelBioFire Defense, LLCK170883, DEN160048
FilmArray Warrior Control PanelMaine Molecular Quality Controls, Inc.K163522
ProGastro SSCS AssayGen-Probe Prodesse, Inc.K123274
xTAG Gastrointestinal Pathogen Panel (GPP)Luminex Molecular Diagnostics, Inc.K121894K121454
BD MAX Extended Enteric Bacterial Panel, BD MAX SystemBecton Dickinson and CompanyK170308
FILMARRAY GASTROINTESTINAL (GI) PANELBIOFIRE DIAGNOSTICSK140407, K160459, K160459/S001
Great Basin Stool Bacterial Pathogens PanelGreat Basin Scientific, Inc.K163571, K163571/S001
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSISLUMINEX MOLECULAR DIAGNOSTICS INC.K140377, K140647
VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP)NANOSPHERE, INCK140083, K142033
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.DEN160025, DEN160025/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.K112937, K132468
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
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 ACepheidK172126
Shiga ToxinGreat Basin Shiga Toxin Direct TestGreat Basin Scientific, Inc.K152955, K152955/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 CorporationK161182, K161182/S001
Xpert TVCepheidK151565, K151565/S001, K161619
Transport MediaPRIMESTORE MTMLonghorn Vaccines and Diagnostics LLCDEN170029
Variola Variola Virus Real-Time PCR AssayCenters for Disease Control and PreventionDEN160016, DEN160016/S001
Yersinia pestisJBAIDS Plague Detection KitIdaho Technology, Inc.K072631

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