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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/Use Trade Name Manufacturer Submission
Acute Myeloid Leukemia Vysis D7S486/CEP 7 FISH Probe Kit Abbott Molecular Inc. K131508
Vysis EGR1 FISH Probe Kit Abbott Molecular Inc. K123951,K091960
LeukoStrat CDx FLT3 Mutation Assay INVIVOSCRIBE TECHNOLOGIES, INC P160040
Abbott RealTime IDH2 ABBOTT MOLECULAR, INC. P170005
Abbott RealTime IDH1 ABBOTT MOLECULAR, INC. P170041
Acute Myeloid Leukemia or Myelodysplastic Syndrome VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION ABBOTT MOLECULAR, INC. DEN130010
Aggressive Systemic Mastocytosi KIT D816V ASSAY ARUP LABARATORIES H140006
Autosomal Recessive Carrier Screening 23ANDME PERSONAL GENOME SERVICE 23andMe DEN140044
B-cell chronic lymphocytic leukemia VYSIS CLL FISH PROBE KIT ABBOTT MOLECULAR, INC K100015
VYSIS CLL FISH PROBE KIT ABBOTT MOLECULAR, INC P150041
CEP 12 SpectrumOrange Direct Labeled Chromosome Enumeration DNA Probe Vysis K962873
Bladder Cancer Vysis UroVysion Bladder Cancer Recurrence Kit Vysis K033982, K013785, K011031
Breast Cancer 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) 23andMe DEN170046
Prosigna Breast Cancer Prognostic Gene Signature Assay Nanostring Technologies K130010
MammaPrint Agendia BV K101454, K081092, K080252, K070675, K062694
INFORM HER2 Dual ISH DNA Probe Cocktail Ventana Medical Systems, Inc. P100027
HER2 CISH pharmDxTM Kit Dako Denmark A/S P100024
GeneSearch Breast Lymph Node (BLN) Test Kit Veridex, LLC. P060017 S001-S004
Dako TOP2A FISH PharmDx Kit Dako Denmark A/S P050045 S001-S004
HER2 IQFISH PHARMDX DAKO DENMARK A/S P040005
INSITE HER-2/NEU KIT BIOGENEX LABORATORIES, INC. P040030
SPOT-LIGHT HER2 CISH KIT INVITROGEN CORPORATION P050040
INFORM HER-2/NEU VENTANA MEDICAL SYSTEMS, INC. P940004
DAKO HERCEPTEST DAKO A/S P980018
PATH VYSION HER-2 DNA PROBE KIT ABBOTT MOLECULAR, INC. P980024
DakoCytomation Her2 FISH pharmDx™ Kit DakoCytomation Denmark A/S P040005
Therascreen PIK3CA RGQ PCR Kit QIAGEN GMBH P190001
Therascreen PIK3CA RGQ PCR Kit QIAGEN GMBH P190004
Chromosome abnormalities Affymetrix CytoScan Dx Assay Affymetrix, Inc. K130313
AneuVysion Vysis K010288, K972200
CYTOSCAN(R) DX Affymetrix, Inc. DEN130018
GenetiSure Dx Postnatal Assay Agilent Technologies, Inc. K163367
CEP 8 Spectrumorange DNA Probe Kit Vysis K953591
CEP X SpectrumOrange/ Y SpectrumGreen DNA Probe Kit Vysis K954214
Chronic Myeloid Leukemia Quantidex qPCR BCR-ABL IS Kit ASURAGEN, INC. DEN160003
Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s And GeneXpert Infinity-80 Systems Cepheid K190076
QXDx BCR-ABL %IS Kit For Use On The QXDx AutoDG DdPCR System Bio-Rad Laboratories, Inc. K181661
MRDx BCR-ABL Test, MRDx BCR-ABL Test Software MolecularMD Corporation K173492
Coagulation Factors Invader Factor V Hologic, Inc. K100980
Invader Factor II Hologic, Inc. K100943
Illumina VeraCode Genotyping Test for Factor V and Factor II Illumina, Inc. K093129
eSensor Thrombophilia Risk Test, eSensor FII-FV Genotyping Test, eSensor Fll Genotyping Test, eSensor FV Genotyping Test, eSensor MTHFR Genotyping Test Osmetech Molecular Diagnostics K093974
Xpert HemosIL FII & FV Cepheid K082118
Verigene F5 Nucleic Acid Test
Verigene F2 Nucleic Acid Test
Verigene MTHFR Nucleic Acid Test
Nanosphere, Inc. K070597
INFINITI System Autogenomics, Inc. K060564
Factor II (Prothrombin) G20210A Kit Roche Diagnostics Corporation K033612
Factor V leiden Kit Roche Diagnostics Corporation K033607
Invader MTHFR 677 Hologic, Inc. K100987
Invader MTHFR 1298 Hologic, 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 THROMBOPHILIA PERSONAL GENOME SERVICE (PGS) GENETIC HEALTH RISK TEST FOR HEREDITARY THROMBOPHILIA 23andME DEN160026
Colorectal Cancer Cologuard Exact Sciences Corporation P130017
Therascreen KRAS RGQ PCR Kit QIAGEN MANCHESTER LTD P110027/P110030
Epi ProColon® Epigenomics AG P130001
Cobas KRAS MUTATION TEST Roche Molecular Systems, Inc. P140023
Praxis Extended RAS Panel Illumina, 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 ANTIBODY Ventana Medical Systems DEN170030
Colorectal Cancer Predisposition MUTYH-Associated Polyposis (MAP) 23andMe K182784
Cystic Fibrosis Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay Illumina, Inc K132750
Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay Illumina, Inc K124006
xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR Luminex Molecular Diagnostics, Inc. K163336
xTAG Cystic Fibrosis 39 Kit v2 Luminex Molecular Diagnostics, Inc. K163347
eSensor CF Genotyping Test Osmetech Molecular Diagnostics K090901
xTAG Cystic Fibrosis 60 Kit v2 Luminex Molecular Diagnostics Inc. K083845
xTAG Cystic Fibrosis 39 Kit v2 Luminex Molecular Diagnostics Inc. K083846
Verigene CFTR and Verigene CFTR PolyT Nucleic Acid Tests Nanosphere, Inc K083294
InPlex CF Molecular Test Third Wave Technology, Inc. K063787
Cystic Fibrosis Genotyping Assay Celera Diagnostics K062028
Tag-It Cystic Fibrosis Kit Tm Bioscience Corporation K060627, K043011
eSensor Cystic Fibrosis Carrier Detection System Clinical Micro Sensors, Inc. K060543, K051435
Drug metabolizing enzymes xTAG CYP2D6 Kit v3 Luminex Molecular Diagnostics, Inc. K130189, K093420
xTAG CYP2D6 Kit v3 Luminex Molecular Diagnostics, Inc. K130189, K131565
Spartan RX CYP2C19 Test System Spartan Bioscience, Inc. K123891
Verigene CYP2C 19 Nucleic Acid Test Nanosphere, Inc. K120466
INFINITI CYP2C19 Assay AutoGenomics, Inc. K101683
Invader UGT1A1 Molecular Assay Third Wave Technologies Inc. K051824
Roche AmpliChip CYP450 microarray Roche Molecular Systems, Inc. K043576, K042259
eSensor Warfarin Sensitivity Saliva Test GenMark Diagnostics K110786
eQ-PCR LC Warfarin Genotyping kit TrimGen Corporation K073071
eSensor Warfarin Sensitivity Test and XT-8 Instrument Osmetech Molecular Diagnostics K073720
Gentris Rapid Genotyping Assay - CYP2C9 & VKORCI ParagonDx, LLC K071867
INFINITI 2C9 & VKORC1 Assay for Warfarin AutoGenomics, Inc. K073014
Verigene Warfarin Metabolism Nucleic Acid Test and Verigene System Nanosphere, Inc. K070804
XTAG CYP2C19 KIT V3 LUMINEX MOLECULAR DIAGNOSTICS, INC. K131565
Heart Transplant AlloMap Molecular Expression Testing xDx K073482
Hematologic Malignancies MLL (KMT2A) BREAKAPART FISH PROBE KIT; AML1 (RUNX1) BREAKAPART FISH PROBE KIT, P53 (TP53) DELETION FISH PROBE KIT; EVI1 (MECOM) BREAKAPART FISH PROBE KIT, DEL(20Q) DELETION FISH PROBE KIT; AML1/ETO (RUNX1/RUNXIT1)) TRANSLOCATION, DUAL FUSI, CBFB (CBFB) /MYH11 TRANSLOCATION, DUAL FUSION FISH PROBE KIT,DEL(5Q)DELETION FISH PROBE KIT; DEL(7Q)DELETION FISH PROBE KIT CYTOCELL LTD DEN170070
HEREDITARY THROMBOPHILIA IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST SEQUENOM, INC./AGENA Bioscience K132978
Melanoma Roche cobas DNA Sample Preparation Kit, COBAS 4800 BRAF V600 MUTATION TEST Roche Molecular Systems, Inc. P110020
THXID-BRAF KIT BioMerieux, Inc. P120014
Multiple Myeloma / Acute Lymphoblastic Leukemia (MRD) ADAPTIVE BIOTECHNOLOGIES CLONOSEQ ASSAY ADAPTIVE BIOTECHNOLOGIES CORPORATION DEN170080
Myelodysplastic syndrome / myeloproliferative disease Fluorescence in situ hybridization, platelet-derived growth factor receptor, beta polypeptide (pdgfrb), rearrangement ARUP LABARATORIES H140005
Myeloproliferative disease / Polycythemia Vera Ipsogen JAK2 RGQ PCR Kit QIAGEN INC DEN160028
Myeloproliferative disease / Polycythemia Vera Ipsogen JAK2 RGQ PCR Kit QIAGEN INC K172287
Non-Small Cell Lung Cancer VYSIS ALK BREAK APART FISH PROBE KIT ABBOTT MOLECULAR, INC. P110012
Cobas EGFR MUTATION TEST v2 Roche Molecular Systems, Inc. P120019
THERASCREEN EGFR RGQ PCR KIT QIAGEN MANCHESTER LTD P120022
Cobas EGFR MUTATION TEST v2 Roche Molecular Systems, Inc. P150044
Cobas EGFR MUTATION TEST v2 Roche Molecular Systems, Inc. P150047
Oncomine Dx Target Test LIFE TECHNOLOGIES CORPORATION P160045
Ovarian Cancer BRACAnalysis CDx Myriad Genetic Laboratories, Inc. P140020
FoundationFocus CDxBRCA FOUNDATION MEDICINE, INC P160018
Pharmacogenetic Reports 23ANDME PERSONAL GENOME SERVICE (PGS) PHARMACOGENETIC REPORTS 23andMe DEN180028
Platforms, Imaging Systems, and Reagents ILLUMINA MISEQDX PLATFORM Illumina, Inc DEN130011
MISEQDX UNIVERSAL KIT 1.0 Illumina, Inc. DEN130042
DUET SYSTEM BIOVIEW LTD. K130775
Prostate Cancer NADiA ProsVue Iris Molecular Diagnostics K101185
PROGENSA PCA3 Assay Gen-Probe, Inc. P100033
Severe Combined Immunodeficiency Disorder (SCID) PerkinElmer Enlite TREC Test System Wallac OY DEN140010
Tissue of Origin Pathwork Tissue of Origin Test Kit – FFPE Pathwork Diagnostics Inc. K120489, K092967
Pathwork Tissue of Origin Test Pathwork Diagnostics Inc. K080896
Tissue of Origin Test Kit - FFPE Cancer Genetics, Inc. K173839
Tumor Profiling MSK-IMPACT (Integrated Mutation Profiling Of Actionable Cancer Targets):A Hybridization-Capture Based Next Generation Sequencing Assay Memorial Sloan-Kettering Cancer Center DEN170058
FoundationOne CDx Foundation Medicine, Inc. P170019
Tumor Profiling Myriad myChoice CDx Myriad Genetic Laboratories, Inc. P190014
Urothelial Cancer Therascreen FGFR RGQ RT-PCR Kit QIAGEN GmbH P180043

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List of Microbial Tests

Microorganism Trade Name Manufacturer Submission
Adenovirus Adenovirus R-gene US Argene SA K121942
Lyra Adenovirus Assay Quidel Corportation K141931
ProAdeno+ Assay Gen-Probe Prodesse, Inc. K102952
Prodesse ProAdeno + Assay Gen-Probe Prodesse, Inc. K132159
Antimicrobial resistance GenePOC Carba GenePOC Inc. K190275
Bacillus Anthracis JBAIDS Anthrax Detection System Idaho Technology, Inc. K131930K071188, K051713  
Bacterial vaginosis (BV) markers Aptima BV Assay Hologic, Inc. K190452

Bordetella

ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit Luminex Corporation K163626, K163626/S001
AMPLIVUE BORDETELLA ASSAY QUIDEL CORPORATION K143206
Great Basin Bordetella Direct Test Great Basin Scientific, Inc. K170284
ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT ILLUMIPRO-10 AUTOMATED ISOTHERMA MERIDIAN BIOSCIENCE, INC. K133673, K152285
SIMPLEXA BORDETELLA DIRECT, SIMPLEXA BORDETELLA POSITIVE CONTROL PACK DIASORIN MOLECULAR LLC K173498
SIMPLEXA BORDETELLA DIRECT, SIMPLEXA BORDETELLA POSITIVE CONTROL PACK DIASORIN MOLECULAR LLC K183223
Candida tropicalis / Candida albicans / Candida parapsilosis / Candida glabrata / Candida krusei   Affirm VPIII Microbial Identification Test Microprobe Corp. K931151K931374
Yeast Traffic Light PNA FISH AdvanDx, Inc. K093024K080719
C. albicans / C. glabrata PNA FISH AdvanDx, Inc. K092784
C. albicans PNA FISH AdvanDx, Inc. K092655K062461
C. Albicans screen Carr-Scarborough Microbiologicals, Inc. K891476
T2Candida 1.1 Panel T2 Biosystems, Inc. K173536
Candida glabrata / Candida
species group / Trichomonas vaginalis (TV)
Aptima CV/TV Assay Candida glabrata / Candida
species group / Trichomonas vaginalis (TV)
K190472
Clostridium difficile ARIES C. difficile Complete Kit, ARIES C. difficile Assay Protocol File Kit Luminex K171441
Solana C. difficile Assay Quidel Corporation K170491
ICEPlex C. difficile Kit PrimeraDx K132726
IMDx C. difficile for Abbott m2000 Intelligent Medical Devices, Inc. K132235
BD Diagnostics BD MAX Cdiff Assay GeneOhm Sciences Canada Inc. K130470
Quidel Molecular Direct C. difficile Assay Quidel Corporation K123998
Verigene C. Difficile Nucleic acid Test Nanosphere, Inc. K123197
Portrait Toxigenic C. difficile Assay Great Basin Scientific, Inc. K113358
Simplexa C. difficile Universal Direct Assay Focus Diagnostics, Inc. K113433, K163085, K163085/S001
Xpert C. difficile/Epi Cepheid K110203
Illumigene C. difficile DNA Amplification Assay Meridian Bioscience, Inc. K110012
Illumigene C. difficile Assay Meridian Bioscience, Inc. K100818, K110012
Xpert C. difficile Cepheid K091109
ProGastro Cd Assay Prodesse Inc. K090239
BD GeneOhm C. diff Assay BD Diagnostics/ GeneOhm Sciences, Inc. K081920
ARTUS C. DIFFICILE QS-RGQ MDX KIT QIAGEN, GMBH K133936
AMPLIVUE C. DIFFICILE ASSAY QUIDEL CORPORATION K123355
GenePOC CDiff GenePOC Inc K172569
Cobas Cdiff Nucleic Acid Test For Use On The Cobas Liat System Roche Molecular Systems, Inc. K171770
Clostridium difficile QC material Cepheid Xpert C. Difficile/Epi Control Panel Microbiologics, Inc. K190463
Coxiella burnetii Joint Biological Agent Identification and Diagnostic System (JBAIDS) Q Fever Detection Kit Idaho Technology, Inc. K103207
Chlamydia trachomatis / Neisseria gonorrhoeae Abbott RealTime CT/NG and Multi-Collect Specimen Collection Kit Abbott Molecular Inc. K092704K080739
Accuprobe Neisseria gonorrhoeae Culture Confirmation Test Gen-Probe, Inc. K895583
Amplicor Chlamydia trachomatis Test Roche Molecular Systems, Inc. K922906
AMPLICOR CT/NG Test for Chlamydia trachomatis Roche Molecular Systems, Inc. K973707
AMPLICOR CT/NG test for Chlamydia trachomatis Roche Diagnostics Corp. K070174
AMPLICOR CT/NG test for Neisseria gonorrhoeae Roche Diagnostics Corp. K070172
APTIMA Combo 2 Assay Gen-Probe, Inc. K111409
APTIMA Combo 2 Assay (Panther System) Hologic/Gen-Probe, Inc. K132251
BD MAX CT/GC/TV, BD MAX Instrument Becton, Dickinson, & Co. K151589, K151589/S001, K151589/S002
BD ProbeTec Chlamydia trachomatis (CT) Qx Amplified DNA Assay Becton, Dickinson, & Co. K091724K090824, K081824
BD Probetec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Becton, Dickinson, & Co. K091730K090971, K090827K081825
BD ProbeTec Chlamydia trachomatis (CT) Qx Amplified DNA Assay on the BD Viper LT System Becton, Dickinson, & Co. K140446
BD Probetec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay on the BD Viper LT System Becton, Dickinson, & Co. K140048
BDProbeTec ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays Becton Dickinson Microbiology Systems K984631
BDProbeTec ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays Becton, Dickinson, & Co. K012351
binx health io CT/NG Assay binx health, Inc. K191352
COBAS 4800 CT/NG Test Roche Molecular Systems, Inc. K110923
COBAS AMPLICOR CT/NG test for Chlamydia trachomatis Roche Molecular Systems, Inc. K973718
COBAS AMPLICOR CT/NG test for Chlamydia trachomatis Roche Diagnostics Corp. K053287
COBAS AMPLICOR CT/NG test for Neisseria gonorrhoeae Roche Molecular Systems, Inc. K974342
COBAS AMPLICOR CT/NG test for Neisseria gonorrhoeae Roche Diagnostics Corp. K053289
COBAS CT/NG FOR USE ON COBAS 6800/8800 SYSTEMS Roche Molecular Systems, Inc. K173887
cobas CT/NG v2.0 Test Roche Molecular Systems, Inc. K132270K140887, K163184
GEN-PROBE AMPLIFIED Chlamydia trachomatis Assay Kit Gen-Probe, Inc. K962217
GEN-PROBE APTIMA Assay for Neisseria gonorrhoeae Gen-Probe, Inc. K063664K062440, K043144
GEN-PROBE APTIMA Assay for Chlamydia trachomatis Gen-Probe, Inc. K063451K053446, K043072
GEN-PROBE APTIMA Combo 2 Assay Gen-Probe, Inc. K043224K032554, K003395
GEN-PROBE PACE 2C System for Chlamydia trachomatis and Neisseria gonorrhoeae Gen-Probe, Inc. K940979
GONOSPOT DNA Probe Culture Confirmation Test Ortho Diagnostic Systems, Inc. K872628
GONOSTAT Gonococcal Detection Kit Sierra Diagnostics, Inc. K991268
Hybrid Capture II CT/GC Test Digene Corp. K981567, K010891
Hybrid Capture II CT-ID Test Digene Corp. K990023, K010892
Hybrid Capture II GC-ID Test Digene Corp. K981485, K010893
LCx Chlamydia trachomatis Assay Abbott Laboratories K934622
LCx Neisseria gonorrhoeae Assay Abbott Laboratories K935833
PACE 2 Chlamydia trachomatis probe confirmation assay Gen-Probe, Inc. K920302
PACE 2 Neisseria gonorrhoeae probe confirmation assay Gen-Probe, Inc. K920301
PACE 2 System for Chlamydia trachomatis Gen-Probe, Inc. K920378
GEN-PROBE PACE System for Chlamydia trachomatis Gen-Probe, Inc. K874878
GEN-PROBE System for Neisseria gonorrhoeae  Gen-Probe, Inc. K874620
PACE System for Neisseria gonorrhoeae Gen-Probe, Inc. K881277
Rapid Diagnostic System for Chlamydia trachomatis Gen-Probe, Inc. K871878
Roche AMPLICOR CT/NG test for Neisseria gonorrhoeae Roche Molecular Systems, Inc. K974503
Roche COBAS AMPLICOR Chlamydia trachomatis test Roche Molecular Systems, Inc. K964507
TIGRIS DTS Automated Analyzer APTIMA Assay for Chlamydia trachomatis Gen-Probe, Inc. K061413
TIGRIS DTS GEN-PROBE APTIMA Assay for Neisseria gonorrhoeae Gen-Probe, Inc. K061509
TIGRIS DTS GEN-PROBE APTIMA COMBO 2 Assay Gen-Probe, Inc. K060652
Xpert CT/NG Cepheid K121710
Xpert CT/NG Cepheid K190441
  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 material BD MAX CT/GC/TV 20-DAY QC PANEL MICROBIOLOGICS, INC. K181683
CT/GC QC material Cepheid Xpert CT/NG Control Panel Microbiologics, Inc. K190223
Cytomegalovirus Abbott RealTime CMV Abbott Molecular P160044
ARTUS CMV RGQ MDX Kit QIAGEN P130027 S001-S002
COBAS CMV Test Roche Molecular Systems P160041 S001
COBAS AmpliPrep/COBAS TaqMan CMV Test Roche Molecular Systems P110037 S001-S031
NucliSens CMV pp67 Organon Teknika Corporation K983762
Dengue virus CDC DENV-1-4 Real-Time RT-PCR Assay Centers for Disease Control and Prevention K113336
Entercoccus IMDx Van R for Abbott m2000 Intelligent Medical Devices, Inc. K123753
BD GeneOhm VanR Assay BD Diagnostics (GeneOhm Sciences, Inc.) K102416
Xpert vanA Assay Cepheid K092953
E. faecalis/OE PNA AdvanDx, Inc. K083074
GBS PNA FISH AdvanDx, Inc. K082612
E. faecalis PNA FISH culture identification kit AdvanDx, Inc. K063127
Enteric parasite QC material BD MAX ENTERIC PARASITE CONTROL PANEL, BD MAX ENTERIC PARASITE 20-DAY QC PANEL MICROBIOLOGICS, INC. K181711
Enterovirus NucliSens EasyQ Enterovirus vl.1 Assay bioMérieux, Inc. K093383K063261
Escherichia coli / Klebsiella pneumoniae / Pseudomonas aeroginosa GNR Traffic Light PNA FISH AdvanDx, Inc. K101558
E. coli/P. aeruginosa PNA FISH AdvanDx, Inc. K092236K081309
EK/P aeruginosa PNA FISH AdvanDx, Inc. K092393K081433
E. coli PNA FISH AdvanDx, Inc. K082068
Francisella tularensis JBAIDS Tularemia Detection Kit Idaho Technology, Inc. K072547
Fungal Pathogen Panel EPLEX BLOOD CULTURE IDENTIFICATION PANEL FUNGAL PATHOGEN (BCID-FP) PANEL GENMARK DIAGNOSTICS, INCORPORATED K182690
Gram-Positive / Gram-Negative Bacteria Accelerate Pheno System, Acceleraet Phenotest BC Kit Accelerate Diagnostics DEN160032, DEN160032/S001
Great Basin Staph ID/R Blood Culture Panel Great Basin Scientific, Inc. K152470, K152470/S001
hemoFISH Masterpanel Miacom Diagnostics GMBH K150031, 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) Cepheid K152614, K152614/S001, K160901 (Rectal Swabs)
EPLEX BLOOD CULTURE IDENTIFICATION PANEL - GRAM POSITIVE (BCID-GP) PANEL GENMARK DIAGNOSTICS, INCORPORATED K181663
EPlex Blood Culture Identification Gram Negative (BCID-GN) Panel GenMark Diagnostics, Incorporated K182619
IC-GN IC-Cassette For Use On The IC-System ICubate, Inc. K190341
Gram-Positive / Gram-Negative Bacteria (Antimicrobial resistance) XPERT CARBA-R CEPHEID K173263
Herpes Simplex Virus Aptima Herpes Simpex Viruses 1 & 2 Hologic, Inc. K162673, K162673/S001
ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit  Luminex Corporation K151906
ARIES System Luminex Corporation K160517, K160517/S001
ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD) Luminex Corporation K161495
IsoAmp HSV Assay BioHelix Corporation K111951
MultiCode-RTx Herpes Simplex Virus 1 & 2 Kit EraGen Biosciences, Inc. K111527K100336
BD ProbeTec Herpes Simplex Viruses (HSV I & 2) QX Amplified DNA Assays BD Diagnostic Systems K103798
SIMPLEXA HSV 1&2 DIRECT FOCUS DIAGNOSTICS K133621 (DEN130049)
AMIPLIVUE HSV 1&2 ASSAY QUIDEL CORPORATION K140029
IMDX HSV-1/2 FOR ABBOTT M2000 INTELLIGENT MEDICAL, INC. K140198
SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK FOCUS DIAGNOSTICS K141458, K151565, K151565/S001
SIMPLEXA HSV 1 & 2 DIRECT, SIMPLEXA HSV 1 & 2 Positive Control Pack DIASORIN MOLECULAR LLC K173798
Solana HSV 1+2/VZV Assay Quidel Corporation K162451
ARTUS HSV-1/2 QS-RGQ MDx KIT QIAGEN K142738
SEEGENE ANYPLEX II HSV-1/2 ASSAY SEEGENE K142156
QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY DIAGNOSTIC HYBRIDS INC. K133448 (DEN140004)
SENTOSA SA201 HSV 1/2 QUALITATIVE PCR TEST VELA DIAGNOSTICS USA INC. K172509
HSV 1 & 2 ELITE MGB KIT; ELITE INGENIUS ELITECHGROUP K180559
Hepatitis virus Abbott RealTime HCV Genotype II Abbott Molecular, Inc. P120012 S001-S0016
Abbott Realtime HCV Assay Abbott Molecular, Inc. P100017 S001-S006, S007-S012, S014-S019
Abbott Realtime HBV Assay Abbott Molecular, Inc. P080026 S001-S004, S005-S014, S016-S020
Aptima HCV Quant Dx Assay Hologic, Inc. P160023
COBAS HBV Test Roche Molecular Systems P150014 S001-S008
COBAS HCV Test Roche Molecular Systems P160016
COBAS HCV Test Roche Molecular Systems P150015 S001-S007
COBAS AmpliPrep/COBAS TaqMan HCV test Roche Molecular Systems P060030 S001-S032, S033-S047, S048-S058
COBAS Taqman HBV Test Roche Molecular Systems, Inc. P050028 S001-S027, S028-S047, S048, S050-S057
Versant HCV 3.0 Assay (bDNA) Siemens Healthcare Diagnostics P020022
Versant HCV RNA Qualitative Assay Gen-Probe, Inc. P020011 S001-S007, S008, S009
COBAS AMPLICOR Hepatitis C Virus (HCV) Test Roche Molecular Systems, Inc. P000012 S001-S043, S044-S053, S054-S056
AMPLICOR HCV Test, v2.0 Roche Molecular Systems, Inc. P000010 S001-S024
APTIMA HBV QUANT ASSAY HOLOGIC, INC P170025
Human Metapneumovirus Pro hMPV+ Assay Gen-Probe Prodesse, Inc. K132200K082688, K123838
Quidel Molecular hMPV Assay Quidel Corporation K112490
Quidel Molecular RSV + hMPV Assay Quidel Corporation K131813K122189
Human papillomavirus APTIMA HPV 16 18/45 Genotype Assay Gen-Probe, Inc. P120007 S001-S010
APTIMA HPV Assay Gen-Probe, Inc. P100042 S001-S012
Cervista HPV 16/18 Hologic, Inc. P080015 S001-S012
Cervista HPV HR and Genfind DNA Extraction Kit Hologic, Inc. P080014 S001-S018
COBAS HPV Test Roche Molecular Systems, Inc. P100020 S001-S024
Digene Hybrid Capture 2 High-Risk HPV DNA Test Digene Corporation P890064 S001-S034
BD ONCLARITY HPV ASSAY BECTON, DICKINSON AND COMPANY P160037
Influenza and Respiratory Viruses PLEX-ID Flu assay Abbott Laboratories K121003
Alere i Influenza A & B ALERE SCARBOROUGH, INC D/B/A BINAX, INC K141520, K151464, K151690, K163266
Alere i RSV Alere Scarborough, Inc. K161375
ARIES Flu A/B & RSV Assay Luminex Corporation K161220
artus Infl A/B RG RT-PCR Kit Qiagen GmbH K113323
CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel Centers for Disease Control and Prevention K080570
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel Centers for Disease Control and Prevention K133869K132508, K130551K123905, K111507, K161556
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit Centers for Disease Control and Prevention K161556
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit Centers for Disease Control and Prevention K172091
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL INFLUENZA A/H5 SUBTYPING CENTERS FOR DISEASE CONTROL AND PREVENTION K141859, K153148
CDC Influenza 2009 A (H1N1) pdm Real-Time RT-PCR Panel Centers for Disease Control and Prevention K101564
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel Influenza B Lineage Genotyping Kit Centers for Disease Control and Prevention K181736
XPERT XPRESS FLU/RSV, XPERT Nasopharyngral Sample Collection Kit, XPERT Nasal Sample Collection Kit, GENEXPERT XPRESS II, GENEXPERT XPRESS IV Cepheid K180218
ACCULA RSV TEST MESA BIOTECH, INC. K181443
cobas Liat Influenza A/B & RSV Iquum, Inc. K153544, K153544/S001
ePlex Respiratory Pathogen Panel GenMark Diagnostics, Inc K163636, 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, LLC K123620, K143080, K160068
FilmArray Respiratory Panel 2 (RP2) BioFire Diagnostics, LLC K170604
FilmArray Respiratory Panel EZ (RP EZ) BioFire Diagnostics, LLC K152579, K152579/S001, K152579/S002
FilmArray RP EZ Control Panel M265 Maine Molecular Quality Controls, Inc. K161573
Idylla Respiratory (IFV-RSV) Panel Janssen Pharmaceutica NV K163628, K163629, K163630
IMDx Flu A/B and RSV for Abbott m2000 Intelligent Medical Devices, Inc. K131584
INFLUENZA A SUBTYPING KIT CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION K140851
Influenza A/H5 (Asian lineage) Virus Real-time RT-PCR Primer and Probe Set Centers for Disease Control and Prevention K060159
INFLUENZA B LINEAGE GENOTYPING KIT CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION K140857
JBAIDS Influenza A Subtyping Kit U.S. Army Medical Materiel Development Activity K111778
JBAIDS Influenza A&B Detection Kit U.S. Army Medical Materiel Development Activity K111775, K152523
JBAIDS Influenza A/H5 (Asian lineage) Detection Kit U.S. Army Medical Materiel Development Activity K100287
Liat Influenza A/B Assay IQuum, Inc. K111387
LYRA PARAINFLUENZA VIRUS ASSAY QUIDEL CORPORATION K141927
NxTAG Respiratory Pathogen Panel Luminex Molecular Diagnostics, Inc. K152386, K152386/S001
Prodesse ProFAST Assay Gen-Probe Prodesse, Inc. K132237
Prodesse ProFlu + Assay Gen-Probe Prodesse, Inc. K132129
Prodesse ProParaflu Assay Gen-Probe Prodesse, Inc. K132238K091053
Prodesse ProParaflu Assay Hologic/Gen-Probe Prodesse, Inc. K153223, K132238
ProFlu+ Assay Hologic/Gen-Probe Prodesse, Inc. K153219, K110968, K092500K081030, K073029
ProParaFlu + Assay Prodesse, Inc. K091053
Quidel Molecular Influenza A + B Assay Quidel Corporation K131728K113777, K112172
Simplexa Flu A/B & RSV Focus Diagnostics, Inc. K102170
Simplexa Flu A/B & RSV Direct Focus Diagnostics, Inc. K120413, K142365, K152408
Simplexa Influenza A H1N1 (2009) Focus Diagnostics, Inc . K100148
Solana Influenza A+B Assay Quidel Corporation K161814
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 Flu Cepheid K162456, K162456/S001, K171552
Xpert Flu + RSV Xpress Cepheid K151226, K162331, K162331/S001
Xpert Flu Assay Cepheid K123191K120911, K103766
XPERT FLU/RSV XC ASSAY Cepheid K142045
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 K181289
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 TEST MESA BIOTECH, INC. K171641
Alere I Influenza A & B 2, Alere I Instrument, Alere I Influenza A & B Control Swab Kit Alere Scarborough, Inc. K171792
FilmArray RP2/RP2plus Control Panel Maine Molecular Quality Controls, Inc. K173171
FILMARRAY RESPIRATORY PANEL 2 PLUS (RP2PLUS) BIOFIRE DIAGNOSTICS, LLC DEN170017
Panther Fusion AdV/HMPV/RV Assay Hologic, Inc. K172629
Panther Fusion Paraflu Assay Hologic, Inc. K172282
Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Hologic, Inc. K171963
Solana RSV+HMPV Assay Quidel Corporation K171974
ID NOW Influenza A & B 2 Alere Scarborough, Inc. K190204
ID NOW Influenza A & B 2 Abbott Diagnostics Scarborough, Inc. K191534
Cobas Influenza A/B Nucleic Acid Test For Use On The Cobas Liat System Roche Molecular Systems, Inc K191729
FluChip-8G Influenza A+B Assay InDevR, Inc K182513
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 Prevention K190302
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 2 Alere Scarborough, Inc. K173932
ALERE I INFLUENZA A & B, ALERE I STREP A, ALERE I RSV, ALERE I INFLUENZA A & B 4 Alere Scarborough, Inc. K173932
ALERE I STREP A 2, ALERE I INSTRUMENT, ALERE I STREP A 2 CONTROL SWAB KIT Alere Scarborough, Inc. K173653
Respiratory panel control material Cepheid Xpert Respiratory Control Panel Microbiologics, Inc. K190086
Respiratory panel QIAstat-Dx Respiratory Panel; QIAstat-Dx Analyzer QIAGEN GmbH

 

Leishmaniaspecies SMART Leish U.S. Army Medical Materiel Development Activity K081868
Meningitis/Encephalitis FilmArray Meningitis/Encephalitis(ME) Panel BioFire Diagnostics LLC DEN150013, DEN150013/S001, K160462
Mycobacterium tuberculosis Xpert MTB/RIF Assay Cepheid K131706
BDProbetec ET Mycobacterium tuberculosis complex culture identification kit Becton, Dickinson, & Co. K000884
Amplified Mycobacterium tuberculosis Direct Test Gen-Probe, Inc. P940034
Amplicor Mycobacterium tuberculosis test Roche Molecular Systems, Inc. P940040
SNAP M.tuberculosis complex Syngene, Inc. K900292
Accuprobe Mycobacterium tuberculosis complex Test Gen-Probe, Inc. K896493
Rapid Diagnostic System for Mycobacterium tuberculosis Gen-Probe, Inc. K871795
Rapid Identification Test for Mycobacterium tuberculosis complex Gen-Probe, Inc. K862614
Mycobacterium species Accuprobe Mycobacterium avium complex culture Gen-Probe, Inc. K921435K896494, K897078
Accuprobe Mycobacterium kansasii Identification Test Gen-Probe, Inc. K904463
SNAP Mycobacterium avium complex Syngene, Inc. K900202
Accuprobe Mycobacterium intracellulare Culture Identification Test Gen-Probe, Inc. K897077
Accuprobe Mycobacterium gordonae culture identification Test Gen-Probe, Inc. K896492
Rapid Diagnostic System for Mycobacterium gordonae Gen-Probe, Inc. K890089
Rapid Diagnostic System for Mycobacteria Gen-Probe, Inc. K864597
Rapid Identification Test for Mycobacterium avium Gen-Probe, Inc. K862613
Gen-Probe Mycobacterium Rapid Confirmation System Gen-Probe, Inc. K860782
Mycoplasma Genitalium Aptima Mycoplasma Genitalium Assay Hologic, 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 Kit Roche Molecular Systems, Inc. K190433
Mycoplasma pneumoniae illumigene Mycoplasma Direct DNA Amplification Assay Meridian Bioscience, Inc. K160829
illumigene Mycoplasma DNA Amplification Assay Meridian Bioscience, Inc. K152800, K123423
Multiplex Panel BD Max Vaginal Panel, BD MAX Instrument GeneOhm Sciences Canada DEN160001/ DEN160001/S001
BIOCODE GASTROINTESTINAL PATHOGEN PANEL (GPP) APPLIED BIOCODE, INC. K180041
Curetis Unyvero LRT Application Curetis GmbH DEN170047
ePlex instrument (multiplex) GenMark Diagnostics, Inc K163652, K163652/S001
FilmArray BCID Panel BioFire Defense, LLC K143171, K160457
FilmArray NGDS Warrior Panel BioFire Defense, LLC K170883, DEN160048
FilmArray Warrior Control Panel Maine Molecular Quality Controls, Inc. K163522
NEUMODX GBS ASSAY NEUMODX MOLECULAR, INC. K173725
PANNAT STEC TEST MICRONICS, INC K173330
ProGastro SSCS Assay Gen-Probe Prodesse, Inc. K123274
Biocode Gastrointestinal Pathogen Panel (GPP) Applied Biocode, Inc. K190585
EntericBio Dx Assay Serosep, Ltd. K182703
xTAG Gastrointestinal Pathogen Panel (GPP) Luminex Molecular Diagnostics, Inc. K121894K121454
BD MAX Extended Enteric Bacterial Panel, BD MAX System Becton Dickinson and Company K170308
BD MAX ENTERIC VIRAL PANEL, BD MAX INSTRUMENT Becton Dickinson and Company K181427
FILMARRAY GASTROINTESTINAL (GI) PANEL BIOFIRE DIAGNOSTICS K140407, K160459, K160459/S001
T2BACTERIA PANEL T2 BIOSYSTEMS, INC. K172708
Great Basin Stool Bacterial Pathogens Panel Great Basin Scientific, Inc. K163571, K163571/S001
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS LUMINEX MOLECULAR DIAGNOSTICS INC. K140377, K140647
VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP) NANOSPHERE, INC K140083, K142033
FILMARRAY PNEUMONIA PANEL BioFire Diagnostics, LLC K180966
FILMARRAY PNEUMONIA PANEL PLUS BioFire Diagnostics, LLC K181324
Multiplex Panel (Pneumonia) QC Material FilmArray Pneumonia/Pneumoniaplus Control Maine Molecular Quality Controls, Inc. (MMQCI) K190222
Non-Variola Orthopoxvirus NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET Centers for Disease Control and Prevention K181205
NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET Centers for Disease Control and Prevention DEN070001
Norovirus RIDA GENE Nororvirus GI/GII R-Biopharm AB K171511
XPERT NOROVIRUS GENEXPERT Dx SYSTEMS (GX-I GX-11 GX-IV GX-XVI)  GENEXPERT INFINITY-48 SYSTEM, GENEXPERT INFINITY-48S SYSTEM, GENEXPERT INFINITY-80 SYSTEM CEPHEID K142501
Plasmodium ID-FISH Plasmodium Genus Test Kit, ID-FISh P. falciparum and P. vivax Combo Test ID-FISH Technology, Inc. DEN160025, DEN160025/S001
Rickettsia Rickettsia Real-time PCR Assay Centers for Disease Control and Prevention K170940
Sepsis SeptiCyte LAB Immunexpress, Inc. K163260
Staphylococcus BD Max MRSA Assay BD Diagnostics (GeneOhm Sciences Canada, Inc.) K120138
Staphylococcus QuickFISH BC AdvanDx, Inc. K113371
MRSA/SA ELITe MGB EliTechGroup Epoch Biosciences. K112937, K132468
Verigene Staphylococcus Blood Culture (BC-S) Nucleic Acid Test Nanosphere, Inc. K112424
NucliSENS EasyQ MRSA Assay bioMerieux, Inc. K102740
Xpert MRSA/SA Blood Culture Assay Cepheid K101879K082140
Xpert MRSA/SA Nasal Complete Assay Cepheid K100822
LightCycler MRSA Advanced Test Roche Molecular Systems, Inc K091409
BD GeneOhm MRSA ACP Assay BD Diagnostics (GeneOhm Sciences Canada, Inc.) K093346
S. aureus and/or other Staphylococcus species PNA FISH Culture AdvanDx, Inc. K092166
Xpert MRSA/SA SSTI Assay Cepheid K080837
BD GeneOhM StaphSR Assay BD Diagnostics (GeneOhm Sciences Canada, Inc.) K071026
S. aureus PNA FISH AdvanDx, Inc. K091827K060099
Xpert MRSA Cepheid K070462
IDI-MRSA Assay Infectio Diagnostic, Inc. K042357K033415
MECA XPRESSFISH ADVANDX INC. K140619
COBAS MRSA/SA TEST ROCHE MOLECULAR SYSTEMS INC. K142721
Xpert MRSA NxG Cepheid K162444
Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System Cepheid K190771
Staphylococcus / MRSA Control Material Cepheid Xpert MRSA NxG Control Panel Microbiologics, Inc. K191172
Cepheid Xpert SA Nasal Complete Control Panel Microbiologics, Inc. K191168
Streptococci ARIES GBS Assay Luminex Corporation K162772
Xpert GBS LB Assay Cepheid K121539
illumigene Group A Streptococcus (GBS) DNA Amplification Assay Meridian Bioscience, Inc. K122019
illumigene Group B Streptococcus (GBS) DNA Amplification Assay Meridian Bioscience, Inc. K121044
BD Max GBS Assay Becton, Dickinson, & Co. K111860
Cepheid Smart GBS Assay Cepheid K062948
Xpert GBS Cepheid K060540
IDI-Strep B Assay Infectio Diagnostic, Inc. K022504
Gen-Probe Accuprobe Group B Streptococcus culture identification kit Chugai Pharmaceuticals Co, Ltd. K974572
Accuprobe Streptococcus pneumoniae culture confirmation Gen-Probe, Inc. K902908
ILLUMIGENE GROUP B STREPTOCOCCUS (GBS) DNA AMPLIFICATION ASSAY MERIDIAN BIOSCIENCE, INC. K112125
AMPLIVUE GBS ASSAY QUIDEL CORPORATION K133503
LYRA DIRECT STREP ASSAY QUIDEL CORPORATION K133883 (DEN140005)
AMPLIVUE GAS ASSAY QUIDEL CORPORATION K141173
LIAT STREP A ASSAY IQUUM INC K141338
revogene GenePOC Inc. K170558
GenePOC GBS LB GenePOC Inc. K170557
Solana Strep Complete Assay Quidel Corporation K162274
ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit Luminex Corporation K172402
Xpert Xpress Strep A Cepheid K172126; K173398
GenePOC Strep A GenePOC Inc. K183366
Streptococci / GBS Conrol Material Cepheid Xpert GBS LB Control Panel Microbiologics, Inc. K182472
Shiga Toxin Great Basin Shiga Toxin Direct Test Great Basin Scientific, Inc. K152955, K152955/S001, K152955/S002
Trichomonas vaginalis Affirm VP Microbial Identification Test for Gardnerella vaginalis and Trichomonas vaginalis Microprobe Corp. K923133
Amplivue Trichomonas Assay Quidel Corporation K143329
APTIMA Trichomonas vaginalis (ATV) Assay Gen-Probe, Inc. K102911
APTIMA Trichomonas vaginalis Assay (PANTHER System) Gen-Probe, Inc. K122062
BD ProbeTec Trichomonas vaginalis  (TV) QX Amplified DNA Assay Becton, Dickinson & Co. K130268
Solana Trichomonas Assay Quidel Corporation K161182, K161182/S001
Xpert TV Cepheid K151565, K151565/S001, K161619
Transport Media PRIMESTORE MTM Longhorn Vaccines and Diagnostics LLC DEN170029
Vaginal Panel (Bacterial vaginosis vaginitis) BD MAX Vaginal Panel GeneOhm Sciences Canada, Inc. (BD Diagnostics) DEN160001
Varicella-zoster viruses Simplexa VZV Direct, Simplexa VZV Positive Control Pack DiaSorin K190219
Variola  Variola Virus Real-Time PCR Assay Centers for Disease Control and Prevention DEN160016, DEN160016/S001
Yersinia pestis JBAIDS Plague Detection Kit Idaho Technology, Inc. K072631

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