U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Products and Medical Procedures
  4. In Vitro Diagnostics
  5. Nucleic Acid Based Tests
  1. In Vitro Diagnostics

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.

On this page:


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
Acute Myeloid Leukemia Vysis EGR1 FISH Probe Kit Abbott Molecular Inc. K123951, K091960
Acute Myeloid Leukemia LeukoStrat CDx FLT3 Mutation Assay INVIVOSCRIBE TECHNOLOGIES, INC P160040
Acute Myeloid Leukemia Abbott RealTime IDH2 ABBOTT MOLECULAR, INC. P170005
Acute Myeloid Leukemia 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
B-cell chronic lymphocytic leukemia VYSIS CLL FISH PROBE KIT ABBOTT MOLECULAR, INC P150041
B-cell chronic lymphocytic leukemia 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
Breast Cancer Prosigna Breast Cancer Prognostic Gene Signature Assay Nanostring Technologies K130010
Breast Cancer MammaPrint Agendia BV K101454, K081092, K080252, K070675, K062694
Breast Cancer MammaPrint FFPE NGS Kit Agendia, Inc. K210973
Breast Cancer INFORM HER2 Dual ISH DNA Probe Cocktail Ventana Medical Systems, Inc. P100027
Breast Cancer HER2 CISH pharmDxTM Kit Dako Denmark A/S P100024
Breast Cancer HER2 Dual ISH DNA Probe Cocktail Ventana Medical Systems, Inc. P190031
Breast Cancer GeneSearch Breast Lymph Node (BLN) Test Kit Veridex, LLC. P060017 S001-S004
Breast Cancer Dako TOP2A FISH PharmDx Kit Dako Denmark A/S P050045 S001-S004
Breast Cancer HER2 IQFISH PHARMDX DAKO DENMARK A/S P040005
Breast Cancer INSITE HER-2/NEU KIT BIOGENEX LABORATORIES, INC. P040030
Breast Cancer SPOT-LIGHT HER2 CISH KIT INVITROGEN CORPORATION P050040
Breast Cancer INFORM HER-2/NEU VENTANA MEDICAL SYSTEMS, INC. P940004
Breast Cancer DAKO HERCEPTEST DAKO A/S P980018
Breast Cancer PATH VYSION HER-2 DNA PROBE KIT ABBOTT MOLECULAR, INC. P980024
Breast Cancer DakoCytomation Her2 FISH pharmDx™ Kit DakoCytomation Denmark A/S P040005
Breast Cancer Therascreen PIK3CA RGQ PCR Kit QIAGEN GMBH P190001
Breast Cancer Therascreen PIK3CA RGQ PCR Kit QIAGEN GMBH P190004
Cell-free DNA blood collection device Cell-Free DNA BCT Streck, Inc. DEN200001
Chromosome abnormalities Affymetrix CytoScan Dx Assay Affymetrix, Inc. K130313
Chromosome abnormalities AneuVysion Vysis K010288, K972200
Chromosome abnormalities CYTOSCAN(R) DX Affymetrix, Inc. DEN130018
Chromosome abnormalities GenetiSure Dx Postnatal Assay Agilent Technologies, Inc. K163367
Chromosome abnormalities CEP 8 Spectrumorange DNA Probe Kit Vysis K953591
Chromosome abnormalities CEP X SpectrumOrange/ Y SpectrumGreen DNA Probe Kit Vysis K954214
Chronic Myeloid Leukemia Quantidex qPCR BCR-ABL IS Kit ASURAGEN, INC. DEN160003
Chronic Myeloid Leukemia Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s And GeneXpert Infinity-80 Systems Cepheid K190076
Chronic Myeloid Leukemia QXDx BCR-ABL %IS Kit For Use On The QXDx AutoDG DdPCR System Bio-Rad Laboratories, Inc. K181661
Chronic Myeloid Leukemia MRDx BCR-ABL Test, MRDx BCR-ABL Test Software MolecularMD Corporation K173492
Coagulation Factors Invader Factor V Hologic, Inc. K100980
Coagulation Factors Invader Factor II Hologic, Inc. K100943
Coagulation Factors Illumina VeraCode Genotyping Test for Factor V and Factor II Illumina, Inc. K093129
Coagulation Factors 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
Coagulation Factors Xpert HemosIL FII & FV Cepheid K082118
Coagulation Factors Verigene F5 Nucleic Acid Test
Verigene F2 Nucleic Acid Test
Verigene MTHFR Nucleic Acid Test
Nanosphere, Inc. K070597
Coagulation Factors INFINITI System Autogenomics, Inc. K060564
Coagulation Factors Factor II (Prothrombin) G20210A Kit Roche Diagnostics Corporation K033612
Coagulation Factors Factor V leiden Kit Roche Diagnostics Corporation K033607
Coagulation Factors Invader MTHFR 677 Hologic, Inc. K100987
Coagulation Factors 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
Health Risk Assessment System AncestryDNA Factor V Leiden Genetic Health Risk Test Ancestry Genomics, Inc. K192944
Colorectal Cancer Cologuard Exact Sciences Corporation P130017
Colorectal Cancer Therascreen KRAS RGQ PCR Kit QIAGEN MANCHESTER LTD P110027/P110030
Colorectal Cancer Therascreen BRAF V600E RGQ PCR Kit QIAGEN MANCHESTER LTD P190026
Colorectal Cancer Epi ProColon® Epigenomics AG P130001
Colorectal Cancer Cobas KRAS MUTATION TEST Roche Molecular Systems, Inc. P140023
Colorectal Cancer Praxis Extended RAS Panel Illumina, Inc. P160038
Colorectal Cancer 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
Cystic Fibrosis Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay Illumina, Inc K124006
Cystic Fibrosis xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR Luminex Molecular Diagnostics, Inc. K163336
Cystic Fibrosis xTAG Cystic Fibrosis 39 Kit v2 Luminex Molecular Diagnostics, Inc. K163347
Cystic Fibrosis eSensor CF Genotyping Test Osmetech Molecular Diagnostics K090901
Cystic Fibrosis xTAG Cystic Fibrosis 60 Kit v2 Luminex Molecular Diagnostics Inc. K083845
Cystic Fibrosis xTAG Cystic Fibrosis 39 Kit v2 Luminex Molecular Diagnostics Inc. K083846
Cystic Fibrosis Verigene CFTR and Verigene CFTR PolyT Nucleic Acid Tests Nanosphere, Inc K083294
Cystic Fibrosis InPlex CF Molecular Test Third Wave Technology, Inc. K063787
Cystic Fibrosis Cystic Fibrosis Genotyping Assay Celera Diagnostics K062028
Cystic Fibrosis Tag-It Cystic Fibrosis Kit Tm Bioscience Corporation K060627, K043011
Cystic Fibrosis 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
Drug Metabolizing enzymes xTAG CYP2D6 Kit v3 Luminex Molecular Diagnostics, Inc. K130189, K131565
Drug Metabolizing enzymes Spartan RX CYP2C19 Test System Akonni Biosystems Inc. K183530
Drug Metabolizing enzymes TruDiagnosis System Akonni Biosystems Inc K183530
Drug Metabolizing enzymes Verigene CYP2C 19 Nucleic Acid Test Nanosphere, Inc. K120466
Drug Metabolizing enzymes INFINITI CYP2C19 Assay AutoGenomics, Inc. K101683
Drug Metabolizing enzymes Invader UGT1A1 Molecular Assay Third Wave Technologies Inc. K051824
Drug Metabolizing enzymes Roche AmpliChip CYP450 microarray Roche Molecular Systems, Inc. K043576, K042259
Drug Metabolizing enzymes eSensor Warfarin Sensitivity Saliva Test GenMark Diagnostics K110786
Drug Metabolizing enzymes eQ-PCR LC Warfarin Genotyping kit TrimGen Corporation K073071
Drug Metabolizing enzymes eSensor Warfarin Sensitivity Test and XT-8 Instrument Osmetech Molecular Diagnostics K073720
Drug Metabolizing enzymes Gentris Rapid Genotyping Assay - CYP2C9 & VKORCI ParagonDx, LLC K071867
Drug Metabolizing enzymes INFINITI 2C9 & VKORC1 Assay for Warfarin AutoGenomics, Inc. K073014
Drug Metabolizing enzymes Verigene Warfarin Metabolism Nucleic Acid Test and Verigene System Nanosphere, Inc. K070804
Endometrial Cancer VENTANA MMR RxDx Panel Ventana Medical Systems, Inc. P200019
Follicular Lymphoma
(Somatic Gene Mutation Detection System)
Cobas EZH2 Mutation Test Roche Molecular System, Inc. P200014
Fragile X AmplideX Fragile X Dx & Carrier Screen Kit Asuragen, Inc DEN190023
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
Hematologic Malignancies Adaptive Biotechnologies ClonoSEQ Assay Adaptive Biotechnologies Corporation K200009
HEREDITARY THROMBOPHILIA IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST SEQUENOM, INC./AGENA Bioscience K132978
Lung and Colon Cancer Assay ONCO/Reveal Dx Lung & Colon Cancer Assay Pillar Biosciences, Inc. P200011
Lynch Syndrome Test System OncoMate MSI Dx Analysis System Promega Corporation K200129
Melanoma Roche cobas DNA Sample Preparation Kit, COBAS 4800 BRAF V600 MUTATION TEST Roche Molecular Systems, Inc. P110020
Melanoma 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-microbial analyte(s) in patients with suspected sepsis SeptiCyte RAPID Immunexpress, Inc K203748
Non-Small Cell Lung Cancer VYSIS ALK BREAK APART FISH PROBE KIT ABBOTT MOLECULAR, INC. P110012
Non-Small Cell Lung Cancer Cobas EGFR MUTATION TEST v2 Roche Molecular Systems, Inc. P120019
Non-Small Cell Lung Cancer THERASCREEN EGFR RGQ PCR KIT QIAGEN MANCHESTER LTD P120022
Non-Small Cell Lung Cancer Cobas EGFR MUTATION TEST v2 Roche Molecular Systems, Inc. P150044
Non-Small Cell Lung Cancer Cobas EGFR MUTATION TEST v2 Roche Molecular Systems, Inc. P150047
Non-Small Cell Lung Cancer Oncomine Dx Target Test LIFE TECHNOLOGIES CORPORATION P160045
Ovarian Cancer BRACAnalysis CDx Myriad Genetic Laboratories, Inc. P140020
Ovarian Cancer FoundationFocus CDxBRCA FOUNDATION MEDICINE, INC P160018
Pharmacogenetic Reports 23ANDME PERSONAL GENOME SERVICE (PGS) PHARMACOGENETIC REPORTS 23andMe DEN180028, DEN180028, K193492, K221885
Platforms, Imaging Systems, and Reagents ILLUMINA MISEQDX PLATFORM Illumina, Inc DEN130011
Platforms, Imaging Systems, and Reagents MISEQDX UNIVERSAL KIT 1.0 Illumina, Inc. DEN130042
Platforms, Imaging Systems, and Reagents DUET SYSTEM BIOVIEW LTD. K130775
Prostate Cancer NADiA ProsVue Iris Molecular Diagnostics K101185
Prostate Cancer PROGENSA PCA3 Assay Gen-Probe, Inc. P100033
Prostate Cancer Predisposition (HOXB13-Related) 23andMe PGS Genetic Risk Report For Hereditary Prostate Cancer (HOXB13-Related) 23andMe, Inc. K211499
Setmelanotide eligibility gene variant detection system POMC/PCSK1/LEPR CDx Panel PreventionGenetics, LLC DEN200059
Severe Combined Immunodeficiency Disorder (SCID) PerkinElmer Enlite TREC Test System Wallac OY DEN140010
Severe Combined Immunodeficiency Disorder (SCID) Eonis SCID-SMA Kit Perkin-Elmer Inc K203035
Saliva DNA Specimen Collection Device AncestryDNA Saliva Collection Kit Ancestry Genomics, Inc. K192947
Spinal Muscular Atrophy Newborn Screening Test System Eonis SCID-SMA Kit Perkin-Elmer Inc DEN200044
Tissue of Origin Pathwork Tissue of Origin Test Kit – FFPE Pathwork Diagnostics Inc. K120489, K092967
Tissue of Origin Pathwork Tissue of Origin Test Pathwork Diagnostics Inc. K080896
Tissue of Origin Tissue of Origin Test Kit - FFPE Cancer Genetics, Inc. K173839
Follicular Lymphoma
(Somatic Gene Mutation Detection System)
Cobas® EZH2 Mutation Test Roche Molecular System, Inc. P200014
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
Tumor Profiling FoundationOne CDx Foundation Medicine, Inc. P170019
Tumor Profiling xT CDx Tempus Labs, Inc. P210011
Tumor Profiling FoundationOne Liquid CDx (F1 Liquid CDx) Foundation Medicine, Inc. P200006
Tumor Profiling Myriad myChoice CDx Myriad Genetic Laboratories, Inc. P190014
Tumor Profiling NYU Langone Genome PACT NYU Langone Medical Center K202304
Tumor Profiling Omics Core NantHealth, Inc.. K190661
Tumor Profiling PGDx elio tissue complete Personal Genome Diagnostics K192063
Tumor Profiling; NSCLC Guardant360® CDx Guardant Health, Inc. P200010
Tumor Profiling, Liquid Biopsy FoundationOne® Liquid CDx Foundation Medicine, Inc. P190032
Urothelial Cancer Therascreen FGFR RGQ RT-PCR Kit QIAGEN GmbH P180043
Whole exome sequencing Helix Laboratory Platform Helix OpCo, LLC DEN190035

List of Microbial Tests

Microorganism Trade Name Manufacturer Submission
Acute febrile illness BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel BioFire Defense, LLC K220870
Adenovirus Adenovirus R-gene US Argene SA K121942
Adenovirus Lyra Adenovirus Assay Quidel Corportation K141931
Adenovirus ProAdeno+ Assay Gen-Probe Prodesse, Inc. K102952
Adenovirus Prodesse ProAdeno + Assay Gen-Probe Prodesse, Inc. K132159
Antimicrobial resistance GenePOC Carba GenePOC Inc. K190275
Antimicrobial resistance Accelerate Pheno System, Accelerate PhenoTest BC Kit Accelerate Diagnostics, Inc. K192665
Antimicrobial resistance Acuitas AMR Gene Panel OpGen, Inc. K191288
Bacillus Anthracis JBAIDS Anthrax Detection System Idaho Technology, Inc. K131930, K071188, K051713
Bacillus Anthracis B. anthracis Real-time PCR Assay Centers for Disease Control and Prevention K192871
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
Bordetella AMPLIVUE BORDETELLA ASSAY QUIDEL CORPORATION K143206
Bordetella Great Basin Bordetella Direct Test Great Basin Scientific, Inc. K170284
Bordetella ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT ILLUMIPRO-10 AUTOMATED ISOTHERMA MERIDIAN BIOSCIENCE, INC. K133673
K152285
Bordetella SIMPLEXA BORDETELLA DIRECT, SIMPLEXA BORDETELLA POSITIVE CONTROL PACK DIASORIN MOLECULAR LLC K173498
Bordetella SIMPLEXA BORDETELLA DIRECT, SIMPLEXA BORDETELLA POSITIVE CONTROL PACK DIASORIN MOLECULAR LLC K183223
Candida tropicalis / Candida albicans / Candida parapsilosiis / Candida glabrata / Candida kruseii Affirm VPIII Microbial Identification Test Microprobe Corp. K931151
K931374
Candida tropicalis / Candida albicans / Candida parapsilosiis / Candida glabrata / Candida kruseii Yeast Traffic Light PNA FISH AdvanDx, Inc. K093024
K080719
Candida tropicalis / Candida albicans / Candida parapsilosiis / Candida glabrata / Candida kruseii C. albicans / C. glabrata PNA FISH AdvanDx, Inc. K092784
Candida tropicalis / Candida albicans / Candida parapsilosiis / Candida glabrata / Candida kruseii C. albicans PNA FISH AdvanDx, Inc. K092655
K062461
Candida tropicalis / Candida albicans / Candida parapsilosiis / Candida glabrata / Candida kruseii C. Albicans screen Carr-Scarborough Microbiologicals, Inc. K891476
Candida tropicalis / Candida albicans / Candida parapsilosiis / Candida glabrata / Candida kruseii 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
Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis BD CTGCTV2 Becton Dickinson and Company K210585
Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis Visby Medical Sexual Health Test Visby Medical K220407
Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and Mycoplasma genitalium Alinity m STI Assay Abbott Molecular, Inc. K202977, K222379
Clostridium difficile ARIES C. difficile Complete Kit, ARIES C. difficile Assay Protocol File Kit Luminex K171441
Clostridium difficile Solana C. difficile Assay Quidel Corporation K170491
Clostridium difficile ICEPlex C. difficile Kit PrimeraDx K132726
Clostridium difficile IMDx C. difficile for Abbott m2000 Intelligent Medical Devices, Inc. K132235
Clostridium difficile BD Diagnostics BD MAX Cdiff Assay GeneOhm Sciences Canada Inc. K130470
Clostridium difficile Quidel Molecular Direct C. difficile Assay Quidel Corporation K123998
Clostridium difficile Verigene C. Difficile Nucleic acid Test Nanosphere, Inc. K123197
Clostridium difficile Portrait Toxigenic C. difficile Assay Great Basin Scientific, Inc. K113358
Clostridium difficile Simplexa C. difficile Universal Direct Assay Focus Diagnostics, Inc. K113433
K163085
K163085/S001
Clostridium difficile Xpert C. difficile/Epi Cepheid K110203
Clostridium difficile Illumigene C. difficile DNA Amplification Assay Meridian Bioscience, Inc. K110012
Clostridium difficile Illumigene C. difficile Assay Meridian Bioscience, Inc. K100818
K110012
Clostridium difficile Xpert C. difficile Cepheid K091109
Clostridium difficile ProGastro Cd Assay Prodesse Inc. K090239
Clostridium difficile BD GeneOhm C. diff Assay BD Diagnostics/ GeneOhm Sciences, Inc. K081920
Clostridium difficile ARTUS C. DIFFICILE QS-RGQ MDX KIT QIAGEN, GMBH K133936
Clostridium difficile AMPLIVUE C. DIFFICILE ASSAY QUIDEL CORPORATION K123355
Clostridium difficile GenePOC CDiff GenePOC Inc K172569
Clostridium difficile Cobas Cdiff Nucleic Acid Test For Use On The Cobas Liat System Roche Molecular Systems, Inc. K171770
Clostridium difficile Great Basin Toxigenic C. difficile Direct Test (CDF2) Vela Operations USA K232092
Clostridium difficile QC material Cepheid Xpert C. Difficile/Epi Control Panel Microbiologics, Inc. K190463
Clostridium difficile Toxin Gene Cobas Cdiff nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc K210385
Clostridium difficile Toxin Gene Cobas Cdiff nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc K212427
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 STIlecular Inc. K092704
K080739
Chlamydia trachomatis / Neisseria gonorrhoeae Accuprobe Neisseria gonorrhoeae Culture Confirmation Test Gen-Probe, Inc. K895583
Chlamydia trachomatis / Neisseria gonorrhoeae Amplicor Chlamydia trachomatis Test Roche Molecular Systems, Inc. K922906
Chlamydia trachomatis / Neisseria gonorrhoeae AMPLICOR CT/NG Test for Chlamydia trachomatis Roche Molecular Systems, Inc. K973707
Chlamydia trachomatis / Neisseria gonorrhoeae AMPLICOR CT/NG test for Chlamydia trachomatis Roche Diagnostics Corp. K070174
Chlamydia trachomatis / Neisseria gonorrhoeae AMPLICOR CT/NG test for Neisseria gonorrhoeae Roche Diagnostics Corp. K070172
Chlamydia trachomatis / Neisseria gonorrhoeae APTIMA Combo 2 Assay Gen-Probe, Inc. K111409
Chlamydia trachomatis / Neisseria gonorrhoeae APTIMA Combo 2 Assay (Panther System) Hologic/Gen-Probe, Inc. K132251
K190515
K220321
Chlamydia trachomatis / Neisseria gonorrhoeae Aptima Combo 2® Assay (Panther® System)
Aptima Combo 2® Assay (Tigris® DTS® System)
Hologic, Inc. K200866
K220321
Chlamydia trachomatis / Neisseria gonorrhoeae BD MAX CT/GC/TV, BD MAX Instrument Becton, Dickinson, & Co. K151589
K151589/S001
K151589/S002
Chlamydia trachomatis / Neisseria gonorrhoeae BD ProbeTec Chlamydia trachomatis (CT) Qx Amplified DNA Assay Becton, Dickinson, & Co. K091724
K090824
K081824
Chlamydia trachomatis / Neisseria gonorrhoeae BD Probetec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Becton, Dickinson, & Co. K091730
K090971
K090827
K081825
Chlamydia trachomatis / Neisseria gonorrhoeae BD ProbeTec Chlamydia trachomatis (CT) Qx Amplified DNA Assay on the BD Viper LT System Becton, Dickinson, & Co. K140446
Chlamydia trachomatis / Neisseria gonorrhoeae BD Probetec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay on the BD Viper LT System Becton, Dickinson, & Co. K140048
Chlamydia trachomatis / Neisseria gonorrhoeae BDProbeTec ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays Becton Dickinson Microbiology Systems K984631
Chlamydia trachomatis / Neisseria gonorrhoeae BDProbeTec ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays Becton, Dickinson, & Co. K012351
Chlamydia trachomatis / Neisseria gonorrhoeae binx health io CT/NG Assay binx health, Inc. K191352
Chlamydia trachomatis / Neisseria gonorrhoeae binx io CT/NG Assay and binx io CT/NG System binx health Inc K200533
Chlamydia trachomatis / Neisseria gonorrhoeae COBAS 4800 CT/NG Test Roche Molecular Systems, Inc. K110923
Chlamydia trachomatis / Neisseria gonorrhoeae COBAS AMPLICOR CT/NG test for Chlamydia trachomatis Roche Molecular Systems, Inc. K973718
Chlamydia trachomatis / Neisseria gonorrhoeae COBAS AMPLICOR CT/NG test for Chlamydia trachomatis Roche Diagnostics Corp. K053287
Chlamydia trachomatis / Neisseria gonorrhoeae COBAS AMPLICOR CT/NG test for Neisseria gonorrhoeae Roche Molecular Systems, Inc. K974342
Chlamydia trachomatis / Neisseria gonorrhoeae COBAS AMPLICOR CT/NG test for Neisseria gonorrhoeae Roche Diagnostics Corp. K053289
Chlamydia trachomatis / Neisseria gonorrhoeae COBAS CT/NG FOR USE ON COBAS 6800/8800 SYSTEMS Roche Molecular Systems, Inc. K173887
Chlamydia trachomatis / Neisseria gonorrhoeae cobas CT/NG v2.0 Test Roche Molecular Systems, Inc. K132270
K140887
K163184
Chlamydia trachomatis / Neisseria gonorrhoeae cobas CTNG for use on cobas 6800/8800 systems Roche Molecular Systems, Inc. K202408
Chlamydia trachomatis / Neisseria gonorrhoeae GEN-PROBE AMPLIFIED Chlamydia trachomatis Assay Kit Gen-Probe, Inc. K962217
Chlamydia trachomatis / Neisseria gonorrhoeae GEN-PROBE APTIMA Assay for Neisseria gonorrhoeae Gen-Probe, Inc. K063664
K062440
K043144
Chlamydia trachomatis / Neisseria gonorrhoeae GEN-PROBE APTIMA Assay for Chlamydia trachomatis Gen-Probe, Inc. K063451
K053446
K043072
Chlamydia trachomatis / Neisseria gonorrhoeae GEN-PROBE APTIMA Combo 2 Assay Gen-Probe, Inc. K043224
K032554
K003395
Chlamydia trachomatis / Neisseria gonorrhoeae GEN-PROBE PACE 2C System for Chlamydia trachomatis and Neisseria gonorrhoeae Gen-Probe, Inc. K940979
Chlamydia trachomatis / Neisseria gonorrhoeae GONOSPOT DNA Probe Culture Confirmation Test Ortho Diagnostic Systems, Inc. K872628
Chlamydia trachomatis / Neisseria gonorrhoeae GONOSTAT Gonococcal Detection Kit Sierra Diagnostics, Inc. K991268
Chlamydia trachomatis / Neisseria gonorrhoeae Hybrid Capture II CT/GC Test Digene Corp. K981567
K010891
Chlamydia trachomatis / Neisseria gonorrhoeae Hybrid Capture II CT-ID Test Digene Corp. K990023
K010892
Chlamydia trachomatis / Neisseria gonorrhoeae Hybrid Capture II GC-ID Test Digene Corp. K981485
K010893
Chlamydia trachomatis / Neisseria gonorrhoeae LCx Chlamydia trachomatis Assay Abbott Laboratories K934622
Chlamydia trachomatis / Neisseria gonorrhoeae LCx Neisseria gonorrhoeae Assay Abbott Laboratories K935833
Chlamydia trachomatis / Neisseria gonorrhoeae PACE 2 Chlamydia trachomatis probe confirmation assay Gen-Probe, Inc. K920302
Chlamydia trachomatis / Neisseria gonorrhoeae PACE 2 Neisseria gonorrhoeae probe confirmation assay Gen-Probe, Inc. K920301
Chlamydia trachomatis / Neisseria gonorrhoeae PACE 2 System for Chlamydia trachomatis Gen-Probe, Inc. K920378
Chlamydia trachomatis / Neisseria gonorrhoeae GEN-PROBE PACE System for Chlamydia trachomatis Gen-Probe, Inc. K874878
Chlamydia trachomatis / Neisseria gonorrhoeae GEN-PROBE System for Neisseria gonorrhoeae Gen-Probe, Inc. K874620
Chlamydia trachomatis / Neisseria gonorrhoeae PACE System for Neisseria gonorrhoeae Gen-Probe, Inc. K881277
Chlamydia trachomatis / Neisseria gonorrhoeae Rapid Diagnostic System for Chlamydia trachomatis Gen-Probe, Inc. K871878
Chlamydia trachomatis / Neisseria gonorrhoeae Roche AMPLICOR CT/NG test for Neisseria gonorrhoeae Roche Molecular Systems, Inc. K974503
Chlamydia trachomatis / Neisseria gonorrhoeae Roche COBAS AMPLICOR Chlamydia trachomatis test Roche Molecular Systems, Inc. K964507
Chlamydia trachomatis / Neisseria gonorrhoeae TIGRIS DTS Automated Analyzer APTIMA Assay for Chlamydia trachomatis Gen-Probe, Inc. K061413
Chlamydia trachomatis / Neisseria gonorrhoeae TIGRIS DTS GEN-PROBE APTIMA Assay for Neisseria gonorrhoeae Gen-Probe, Inc. K061509
Chlamydia trachomatis / Neisseria gonorrhoeae TIGRIS DTS GEN-PROBE APTIMA COMBO 2 Assay Gen-Probe, Inc. K060652
Chlamydia trachomatis / Neisseria gonorrhoeae Xpert CT/NG Cepheid K121710
Chlamydia trachomatis / Neisseria gonorrhoeae Xpert CT/NG Cepheid K190441
Chlamydia trachomatis / Neisseria gonorrhoeae Aptima Combo 2 Assay (Panther System) Hologic, Inc. K190515
Chlamydia trachomatis / Neisseria gonorrhoeae Aptima Neisseria gonorrhoeae Assay Hologic, Inc. K231329
Chlamydia trachomatis / Neisseria gonorrhoeae NeuMoDx CT/NG Assay 2.0 NeuMoDx Molecular, Inc. K230267
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, Inc. P160044
Cytomegalovirus Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit Meridian Bioscience, Inc. DEN180040
Cytomegalovirus Alinity M CMV Abbott Molecular, Inc. P210022
Cytomegalovirus Aptima CMV Quant Assay Hologic, Inc. P210029
Cytomegalovirus ARTUS CMV RGQ MDX Kit QIAGEN P130027
Cytomegalovirus COBAS AmpliPrep/COBAS TaqMan CMV Test Roche Molecular Systems P110037
Cytomegalovirus COBAS CMV Test Roche Molecular Systems P160041
Cytomegalovirus Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack DiaSorin Molecular LLC K202755
Cytomegalovirus 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
EBV Nuclear Antigen-1 DNA / Head and neck cancer associated viruses NP Screen Advance Sentry Corporation DEN190031
EBV / BKV cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit Roche Molecular Systems, Inc K202215
BKV / Quantitative viral nucleic acid test for transplant patient management cobas BKV Roche Molecular Systems, Inc. K203220
EBV / Quantitative viral nucleic acid test for transplant patient management cobas EBV Roche Molecular Systems, Inc. DEN200015
EBV / Quantitative viral nucleic acid test for transplant patient management ALINITY M EBV AMP KIT (LIST NO. 09N43-095), ALINITY M EBV CTRL KIT (LIST NO. 09N43-085), ALINITY M EBV CAL KIT (LIST NO. 09N43-075) Abbott Molecular, Inc. K212778
Entercoccus IMDx Van R for Abbott m2000 Intelligent Medical Devices, Inc. K123753
Entercoccus BD GeneOhm VanR Assay BD Diagnostics (GeneOhm Sciences, Inc.) K102416
Entercoccus Xpert vanA Assay Cepheid K092953
Entercoccus E. faecalis/OE PNA AdvanDx, Inc. K083074
Entercoccus GBS PNA FISH AdvanDx, Inc. K082612
Entercoccus 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. K093383
K063261
Escherichia coli / Klebsiella pneumoniae / Pseudomonas aeroginosa GNR Traffic Light PNA FISH AdvanDx, Inc. K101558
Escherichia coli / Klebsiella pneumoniae / Pseudomonas aeroginosa E. coli/P. aeruginosa PNA FISH AdvanDx, Inc. K092236
K081309
Escherichia coli / Klebsiella pneumoniae / Pseudomonas aeroginosa EK/P aeruginosa PNA FISH AdvanDx, Inc. K092393
K081433
Escherichia coli / Klebsiella pneumoniae / Pseudomonas aeroginosa 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
Gram-Positive / Gram-Negative Bacteria Great Basin Staph ID/R Blood Culture Panel Great Basin Scientific, Inc. K152470
K152470/S001
Gram-Positive / Gram-Negative Bacteria hemoFISH Masterpanel Miacom Diagnostics GMBH K150031
K150031/S001
Gram-Positive / Gram-Negative Bacteria IC-GPC Assay for use on the IC-System (positive blood cultures) iCubate, Inc. K163390
K163390/S001
Gram-Positive / Gram-Negative Bacteria Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Nanosphere, Inc. K122514
K113450
Gram-Positive / Gram-Negative Bacteria Xpert Carba-R (GNR) Cepheid K152614
K152614/S001
K160901 (Rectal Swabs)
Gram-Positive / Gram-Negative Bacteria EPLEX BLOOD CULTURE IDENTIFICATION PANEL - GRAM POSITIVE (BCID-GP) PANEL GENMARK DIAGNOSTICS, INCORPORATED K181663
Gram-Positive / Gram-Negative Bacteria EPlex Blood Culture Identification Gram Negative (BCID-GN) Panel GenMark Diagnostics, Incorporated K182619
Gram-Positive / Gram-Negative Bacteria 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
Herpes simplex Virus ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit Luminex Corporation K151906
Herpes simplex Virus ARIES System Luminex Corporation K160517
K160517/S001
Herpes simplex Virus ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD) Luminex Corporation K161495
Herpes simplex Virus IsoAmp HSV Assay BioHelix Corporation K111951
Herpes simplex Virus MultiCode-RTx Herpes Simplex Virus 1 & 2 Kit EraGen Biosciences, Inc. K111527
K100336
Herpes simplex Virus BD ProbeTec Herpes Simplex Viruses (HSV I & 2) QX Amplified DNA Assays BD Diagnostic Systems K103798
Herpes simplex Virus SIMPLEXA HSV 1&2 DIRECT FOCUS DIAGNOSTICS K133621 (DEN130049)
Herpes simplex Virus AMIPLIVUE HSV 1&2 ASSAY QUIDEL CORPORATION K140029
Herpes simplex Virus illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit Meridian Bioscience, Inc. K151046
Herpes simplex Virus IMDX HSV-1/2 FOR ABBOTT M2000 INTELLIGENT MEDICAL, INC. K140198
Herpes simplex Virus SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK FOCUS DIAGNOSTICS K141458
K151565
K151565/S001
Herpes simplex Virus SIMPLEXA HSV 1 & 2 DIRECT, SIMPLEXA HSV 1 & 2 Positive Control Pack DIASORIN MOLECULAR LLC K173798
Herpes simplex Virus Solana HSV 1+2/VZV Assay Quidel Corporation K162451
Herpes simplex Virus Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument Quidel Corporation K232286
Herpes simplex Virus ARTUS HSV-1/2 QS-RGQ MDx KIT QIAGEN K142738
Herpes simplex Virus SEEGENE ANYPLEX II HSV-1/2 ASSAY SEEGENE K142156
Herpes simplex Virus QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY DIAGNOSTIC HYBRIDS INC. K133448 (DEN140004)
Herpes simplex Virus SENTOSA SA201 HSV 1/2 QUALITATIVE PCR TEST VELA DIAGNOSTICS USA INC. K172509
Herpes simplex Virus HSV 1 & 2 ELITE MGB KIT; ELITE INGENIUS ELITECHGROUP K180559
Hepatitis virus Abbott RealTime HCV Genotype II Abbott Molecular, Inc. P120012 S001-S0016
Hepatitis virus Abbott Realtime HCV Assay Abbott Molecular, Inc. P100017 S001-S006, S007-S012, S014-S019
Hepatitis virus Alinity m HCV Abbott Molecular, Inc. P190025
Hepatitis virus Abbott Realtime HBV Assay Abbott Molecular, Inc. P080026 S001-S004, S005-S014, S016-S020
Hepatitis virus Aptima HCV Quant Dx Assay Hologic, Inc. P160023
Hepatitis virus COBAS HBV Test Roche Molecular Systems P150014 S001-S008
Hepatitis virus Alinity m HBV Abbott Molecular, Inc. P200013
Hepatitis virus COBAS HCV Test Roche Molecular Systems P150015 S001-S007
P160016
K221007
Hepatitis virus COBAS AmpliPrep/COBAS TaqMan HCV test Roche Molecular Systems P060030 S001-S032, S033-S047, S048-S058
Hepatitis virus COBAS Taqman HBV Test Roche Molecular Systems, Inc. P050028 S001-S027, S028-S047, S048, S050-S057
Hepatitis virus Versant HCV 3.0 Assay (bDNA) Siemens Healthcare Diagnostics P020022
Hepatitis virus Versant HCV RNA Qualitative Assay Gen-Probe, Inc. P020011 S001-S007, S008, S009
Hepatitis virus COBAS AMPLICOR Hepatitis C Virus (HCV) Test Roche Molecular Systems, Inc. P000012 S001-S043, S044-S053, S054-S056
Hepatitis virus AMPLICOR HCV Test, v2.0 Roche Molecular Systems, Inc. P000010 S001-S024
Hepatitis virus APTIMA HBV QUANT ASSAY HOLOGIC, INC P170025
Human Metapneumovirus Pro hMPV+ Assay Gen-Probe Prodesse, Inc. K132200
K082688
K123838
Human Metapneumovirus Quidel Molecular hMPV Assay Quidel Corporation K112490
Human Metapneumovirus Quidel Molecular RSV + hMPV Assay Quidel Corporation K131813
K122189
Human Papillomvirus Alinity m HR HPV Abbott Molecular, Inc P230003
Human Papillomvirus APTIMA HPV 16 18/45 Genotype Assay Gen-Probe, Inc. P120007 S001-S010
Human Papillomvirus APTIMA HPV Assay Gen-Probe, Inc. P100042 S001-S012
Human Papillomvirus BD ONCLARITY HPV ASSAY BECTON, DICKINSON AND COMPANY P160037
Human Papillomvirus cobas HPV for use on the cobas 6800/8800 Systems Roche Molecular Systems, Inc P190028
Human Papillomvirus Cervista HPV 16/18 Hologic, Inc. P080015;S001-S012
Human Papillomvirus Cervista HPV HR and Genfind DNA Extraction Kit Hologic, Inc. P080014 S001-S018
Human Papillomvirus COBAS HPV Test Roche Molecular Systems, Inc. P100020 S001-S024
Human Papillomvirus Digene Hybrid Capture 2 High-Risk HPV DNA Test Digene Corporation P890064 S001-S034
Influenza and Respiratory Viruses PLEX-ID Flu assay Abbott Laboratories K121003
Influenza and Respiratory Viruses Alere i Influenza A & B ALERE SCARBOROUGH, INC D/B/A BINAX, INC K141520
K151464
K151690
K163266
Influenza and Respiratory Viruses Alere i RSV Alere Scarborough, Inc. K161375
Influenza and Respiratory Viruses ARIES Flu A/B & RSV Assay Luminex Corporation K161220
Influenza and Respiratory Viruses artus Infl A/B RG RT-PCR Kit Qiagen GmbH K113323
Influenza and Respiratory Viruses CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel Centers for Disease Control and Prevention K080570
Influenza and Respiratory Viruses CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel Centers for Disease Control and Prevention K133869
K132508
K130551
K123905
K111507
K161556
Influenza and Respiratory Viruses CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit Centers for Disease Control and Prevention K161556
Influenza and Respiratory Viruses CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit Centers for Disease Control and Prevention K172091
Influenza and Respiratory Viruses 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 A/H5 Subtyping Kit Centers for Disease Control and Prevention K200370
Influenza and Respiratory Viruses CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL INFLUENZA A/H5 SUBTYPING CENTERS FOR DISEASE CONTROL AND PREVENTION K141859
K153148
Influenza and Respiratory Viruses CDC Influenza 2009 A (H1N1) pdm Real-Time RT-PCR Panel Centers for Disease Control and Prevention K101564
Influenza and Respiratory Viruses CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel Influenza B Lineage Genotyping Kit Centers for Disease Control and Prevention K181736
Influenza and Respiratory Viruses XPERT XPRESS FLU/RSV, XPERT Nasopharyngral Sample Collection Kit, XPERT Nasal Sample Collection Kit, GENEXPERT XPRESS II, GENEXPERT XPRESS IV Cepheid K180218
Influenza and Respiratory Viruses ACCULA RSV TEST MESA BIOTECH, INC. K181443
Influenza and Respiratory Viruses BioCode Respiratory Pathogen Panel (RPP) Applied BioCode, Inc K192485
Influenza and Respiratory Viruses cobas Liat Influenza A/B & RSV Iquum, Inc. K153544
K153544/S001
Influenza and Respiratory Viruses eNAT molecular collection and preservation medium Copan Italia S.p.A. K201849
Influenza and Respiratory Viruses DNA/RNA Shield Collection Tube Zymo Research K202641
Influenza and Respiratory Viruses ePlex Respiratory Pathogen Panel GenMark Diagnostics, Inc K163636
K163636/S001
Influenza and Respiratory Viruses eSensor Respiratory Viral Panel (RVP) Clinical Micro Sensors, Inc. K113731
Influenza and Respiratory Viruses FilmArray Respiratory Panel (RP) Idaho Technology, Inc. K120267
K110764
K103175
Influenza and Respiratory Viruses FilmArray Respiratory Panel (RP) BioFire Diagnostics, LLC K123620
K143080
K160068
Influenza and Respiratory Viruses FilmArray Respiratory Panel 2 (RP2) BioFire Diagnostics, LLC K170604
Influenza and Respiratory Viruses FilmArray Respiratory Panel EZ (RP EZ) BioFire Diagnostics, LLC K152579, K152579/S001, K152579/S002
Influenza and Respiratory Viruses FilmArray RP EZ Control Panel M265 Maine Molecular Quality Controls, Inc. K161573
Influenza and Respiratory Viruses Idylla Respiratory (IFV-RSV) Panel Janssen Pharmaceutica NV K163628
K163629
K163630
Influenza and Respiratory Viruses IMDx Flu A/B and RSV for Abbott m2000 Intelligent Medical Devices, Inc. K131584
Influenza and Respiratory Viruses INFLUENZA A SUBTYPING KIT CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION K140851
Influenza and Respiratory Viruses Influenza A/H5 (Asian lineage) Virus Real-time RT-PCR Primer and Probe Set Centers for Disease Control and Prevention K060159
Influenza and Respiratory Viruses INFLUENZA B LINEAGE GENOTYPING KIT CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION K140857
Influenza and Respiratory Viruses JBAIDS Influenza A Subtyping Kit U.S. Army Medical Materiel Development Activity K111778
Influenza and Respiratory Viruses JBAIDS Influenza A&B Detection Kit U.S. Army Medical Materiel Development Activity K111775
K152523
Influenza and Respiratory Viruses JBAIDS Influenza A/H5 (Asian lineage) Detection Kit U.S. Army Medical Materiel Development Activity K100287
Influenza and Respiratory Viruses Liat Influenza A/B Assay IQuum, Inc. K111387
Influenza and Respiratory Viruses Lyra Influenza A+B Assay Quidel Corporation K230236
Influenza and Respiratory Viruses LYRA PARAINFLUENZA VIRUS ASSAY QUIDEL CORPORATION K141927
Influenza and Respiratory Viruses NxTAG Respiratory Pathogen Panel Luminex Molecular Diagnostics, Inc. K152386
K152386/S001
Influenza and Respiratory Viruses NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software Luminex Molecular Diagnostics, Inc. K193167
Influenza and Respiratory Viruses Prodesse ProFAST Assay Gen-Probe Prodesse, Inc. K132237
Influenza and Respiratory Viruses Prodesse ProFlu + Assay Gen-Probe Prodesse, Inc. K132129
Influenza and Respiratory Viruses Prodesse ProParaflu Assay Gen-Probe Prodesse, Inc. K132238
K091053
Influenza and Respiratory Viruses Prodesse ProParaflu Assay Hologic/Gen-Probe Prodesse, Inc. K153223
K132238
Influenza and Respiratory Viruses ProFlu+ Assay Hologic/Gen-Probe Prodesse, Inc. K153219
K110968
K092500
K081030
K073029
Influenza and Respiratory Viruses ProParaFlu + Assay Prodesse, Inc. K091053
Influenza and Respiratory Viruses Quidel Molecular Influenza A + B Assay Quidel Corporation K131728
K113777
K112172
Influenza and Respiratory Viruses Simplexa Flu A/B & RSV Focus Diagnostics, Inc. K102170
Influenza and Respiratory Viruses Simplexa Flu A/B & RSV Direct Focus Diagnostics, Inc. K120413
K142365
K152408
Influenza and Respiratory Viruses Simplexa Influenza A H1N1 (2009) Focus Diagnostics, Inc . K100148
Influenza and Respiratory Viruses Solana Influenza A+B Assay Quidel Corporation K161814
Influenza and Respiratory Viruses Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Nanosphere, Inc. K143653
K143653/S001
Influenza and Respiratory Viruses Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) Nanosphere, Inc. K103209
K093337
K092957
K092566
K083088
Influenza and Respiratory Viruses Xpert Xpress Flu Cepheid K162456
K162456/S001
K171552
Influenza and Respiratory Viruses Xpert Flu + RSV Xpress Cepheid K151226
K162331
K162331/S001
Influenza and Respiratory Viruses Xpert Flu Assay Cepheid K123191
K120911
K103766
Influenza and Respiratory Viruses XPERT FLU/RSV XC ASSAY Cepheid K142045
Influenza and Respiratory Viruses 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
Influenza and Respiratory Viruses xTAG Respiratory Viral Panel (RVP) Luminex Molecular Diagnostics, Inc. K112781
K112199
K091667
K081483
K063765
Influenza and Respiratory Viruses xTAG Respiratory Viral Panel Fast (RVP FAST) Luminex Molecular Diagnostics, Inc. K103776
Influenza and Respiratory Viruses ACCULA FLU A/FLU B TEST MESA BIOTECH, INC. K171641
Influenza and Respiratory Viruses Alere I Influenza A & B 2, Alere I Instrument, Alere I Influenza A & B Control Swab Kit Alere Scarborough, Inc. K171792
Influenza and Respiratory Viruses FilmArray Respiratory Panel 2.1(RP2.1) BioFire Diagnostics, LLC DEN200031
Influenza and Respiratory Viruses FilmArray RP2/RP2plus Control Panel Maine Molecular Quality Controls, Inc. K173171
Influenza and Respiratory Viruses FILMARRAY RESPIRATORY PANEL 2 PLUS (RP2PLUS) BIOFIRE DIAGNOSTICS, LLC DEN170017
Influenza and Respiratory Viruses Panther Fusion AdV/HMPV/RV Assay Hologic, Inc. K172629
K231017
Influenza and Respiratory Viruses Panther Fusion Paraflu Assay Hologic, Inc. K172282
Influenza and Respiratory Viruses Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Hologic, Inc. K171963
Influenza and Respiratory Viruses Solana RSV+HMPV Assay Quidel Corporation K171974
Influenza and Respiratory Viruses ID NOW Influenza A & B 2 Alere Scarborough, Inc. K190204
Influenza and Respiratory Viruses ID NOW Influenza A & B 2 Abbott Diagnostics Scarborough, Inc. K191534
K220801
Influenza and Respiratory Viruses Cobas Influenza A/B Nucleic Acid Test For Use On The Cobas Liat System Roche Molecular Systems, Inc K191729
Influenza and Respiratory Viruses COBAS INFLUENZA A/B & RSV NUCLEIC ACID TEST FOR USE ON THE COBAS LIAT SYSTEM Roche Molecular Systems, Inc K210234
K213822
Influenza and Respiratory Viruses FluChip-8G Influenza A+B Assay InDevR, Inc K182513
Influenza and Respiratory Viruses 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 cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc K200065
Influenza and Respiratory Viruses Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack DiaSorin Molecular LLC K201505
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
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 4 Alere Scarborough, Inc. K173932
Influenza and Respiratory Viruses
Influenza A & B, Strep A, RSV
ALERE I STREP A 2, ALERE I INSTRUMENT, ALERE I STREP A 2 CONTROL SWAB KIT Alere Scarborough, Inc. K173653
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
Mycobacterium tuberculosis BDProbetec ET Mycobacterium tuberculosis complex culture identification kit Becton, Dickinson, & Co. K000884
Mycobacterium tuberculosis Amplified Mycobacterium tuberculosis Direct Test Gen-Probe, Inc. P940034
Mycobacterium tuberculosis Amplicor Mycobacterium tuberculosis test Roche Molecular Systems, Inc. P940040
Mycobacterium tuberculosis SNAP M.tuberculosis complex Syngene, Inc. K900292
Mycobacterium tuberculosis Accuprobe Mycobacterium tuberculosis complex Test Gen-Probe, Inc. K896493
Mycobacterium tuberculosis Rapid Diagnostic System for Mycobacterium tuberculosis Gen-Probe, Inc. K871795
Mycobacterium tuberculosis Rapid Identification Test for Mycobacterium tuberculosis complex Gen-Probe, Inc. K862614
Mycobacterium species Accuprobe Mycobacterium avium complex culture Gen-Probe, Inc. K921435
K896494
K897078
Mycobacterium species Accuprobe Mycobacterium kansasii Identification Test Gen-Probe, Inc. K904463
Mycobacterium species SNAP Mycobacterium avium complex Syngene, Inc. K900202
Mycobacterium species Accuprobe Mycobacterium intracellulare Culture Identification Test Gen-Probe, Inc. K897077
Mycobacterium species Accuprobe Mycobacterium gordonae culture identification Test Gen-Probe, Inc. K896492
Mycobacterium species Rapid Diagnostic System for Mycobacterium gordonae Gen-Probe, Inc. K890089
Mycobacterium species Rapid Diagnostic System for Mycobacteria Gen-Probe, Inc. K864597
Mycobacterium species Rapid Identification Test for Mycobacterium avium Gen-Probe, Inc. K862613
Mycobacterium species 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
Mycoplasma pneumoniae 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
Multiplex Panel BD MAX Enteric Parasite Panel Becton, Dickinson and Company K220193
Multiplex Panel BIOCODE GASTROINTESTINAL PATHOGEN PANEL (GPP) APPLIED BIOCODE, INC. K180041
Multiplex Panel BioFire Blood Culture Identification 2 (BCID2) Panel BioFire Diagnostics, LLC K193519
Multiplex Panel BioFire Joint Infection (JI) Panel BioFire Diagnostics, LLC DEN200066
Multiplex Panel FilmArray BCID2 Control Panel M416 Maine Molecular Quality Controls, Inc. K200010
Multiplex Panel Curetis Unyvero LRT Application Curetis GmbH DEN170047
Multiplex Panel Unyvero LRT BAL Application Curetis GmbH K191967
Multiplex Panel ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel GenMark Diagnostics, Inc K213236
Multiplex Panel ePlex instrument (multiplex) GenMark Diagnostics, Inc K163652
K163652/S001
Multiplex Panel FilmArray BCID Panel BioFire Defense, LLC K143171, K160457
Multiplex Panel FilmArray NGDS Warrior Panel BioFire Defense, LLC K170883
DEN160048
Multiplex Panel FilmArray Warrior Control Panel Maine Molecular Quality Controls, Inc. K163522
Multiplex Panel NEUMODX GBS ASSAY NEUMODX MOLECULAR, INC. K173725
Multiplex Panel PANNAT STEC TEST MICRONICS, INC K173330
Multiplex Panel ProGastro SSCS Assay Gen-Probe Prodesse, Inc. K123274
Multiplex Panel Biocode Gastrointestinal Pathogen Panel (GPP) Applied Biocode, Inc. K190585
Multiplex Panel EntericBio Dx Assay Serosep, Ltd. K182703
Multiplex Panel xTAG Gastrointestinal Pathogen Panel (GPP) Luminex Molecular Diagnostics, Inc. K121894
K121454
Multiplex Panel BD MAX Extended Enteric Bacterial Panel, BD MAX System Becton Dickinson and Company K170308
K214122
Multiplex Panel BD MAX ENTERIC VIRAL PANEL, BD MAX INSTRUMENT Becton Dickinson and Company K181427
K220607
Multiplex Panel FILMARRAY GASTROINTESTINAL (GI) PANEL BIOFIRE DIAGNOSTICS K140407
K160459
K160459/S001
Multiplex Panel xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) Luminex Molecular Diagnostics, Inc. K191160
Multiplex Panel xTAG Gastrointestinal Pathogen Panel (GPP) Luminex Molecular Diagnostics, Inc. K191161
Multiplex Panel T2Bacteria Panel T2 Biosystems, Inc. K172708
K233184
Multiplex Panel T2Biothreat Panel T2 Biosystems, Inc. K231336
Multiplex Panel xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) Luminex Molecular Diagnostics, Inc. K191160
Multiplex Panel xTAG Gastrointestinal Pathogen Panel (GPP) Luminex Molecular Diagnostics, Inc. K191161
Multiplex Panel Great Basin Stool Bacterial Pathogens Panel Great Basin Scientific, Inc. K163571
K163571/S001
Multiplex Panel XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS LUMINEX MOLECULAR DIAGNOSTICS INC. K140377
K140647
Multiplex Panel VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP) NANOSPHERE, INC K140083
K142033
Multiplex Panel FILMARRAY PNEUMONIA PANEL BioFire Diagnostics, LLC K180966
Multiplex Panel FILMARRAY PNEUMONIA PANEL PLUS BioFire Diagnostics, LLC K181324
K222601
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 DEN070001
K181205
K221658
K221834
K222558
Non-Variola Orthopoxvirus NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET Centers for Disease Control and Prevention DEN070001
Non-viral microorganism(s) causing sexually transmitted infections Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (Instrument And Software), Rheonix Urine Specimen Collection Kit Rheonix, Inc K193081
Non-viral microorganism(s) causing sexually transmitted infections Visby Medical Sexual Health Visby Medical K200748
Non-viral microorganism(s) causing sexually transmitted infections Simple 2 Test LetsGetChecked Inc. DEN200070
Norovirus RIDA GENE Nororvirus GI/GII R-Biopharm AB K171511
Norovirus 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
Respiratory panel BIOFIRE SPOTFIRE Respiratory (R) Panel BioFire Diagnostics, LLC K213954
Respiratory panel BIOFIRE SPOTFIRE Respiratory (R) Panel Mini BioFire Diagnostics, LLC K230719
Respiratory panel QIAstat-Dx Respiratory Panel; QIAstat-Dx Analyzer QIAGEN GmbH K183597
Respiratory panel FilmArray Pneumonia Panel BioFire Diagnostics, LLC K212727
Respiratory panel control material Cepheid Xpert Respiratory Control Panel Microbiologics, Inc. K190086
Respiratory panel control material BioFire RP2.1/RP2.1plus Control Panel M441 Main Molecular Quality Controls, Inc. K202196
Rickettsia Rickettsia Real-time PCR Assay Centers for Disease Control and Prevention K170940
SARS-CoV-2 respiratory infection and other microbial agents BioFire COVID-19 Test 2 BioFire Defense, LLC K211079
K221460
SARS-CoV-2 respiratory infection and other microbial agents Simplexa COVID-19 Direct DiaSorin Molecular LLC K212147
SARS-CoV-2 respiratory infection and other microbial agents cobas SARS-Cov-2 Qualitative For Use On The Cobas 6800/8800 Systems Roche Molecular Systems, Inc. K213804
K231306
SARS-CoV-2 respiratory infection and other microbial agents cobas SARS-CoV-2 & Influenza A/B for use on the cobas Liat System Roche Molecular Systems, Inc. K223591
SARS-CoV-2 respiratory infection and other microbial agents cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc. K223783
SARS-CoV-2 respiratory infection and other microbial agents Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay Hologic, Inc. K222736
SARS-CoV-2 respiratory infection and other microbial agents BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System BD Integrated Diagnostic Solutions K230956
SARS-CoV-2 respiratory infection and other microbial agents Xpert Xpress CoV-2/Flu/RSV plus Cepheid K231481
SARS-CoV-2 respiratory infection and other microbial agents Xpert Xpress CoV-2 plus Cepheid K230440
Over-The-Counter Molecular Test To Detect Sars-Cov-2 Cue COVID-19 Molecular Test Cue Health Inc. DEN220028
K232643
Simple point-of-care device to detect sar-cov-2 nucleic acid targets ID NOW COVID-19 2.0 Abbott Diagnostics Scarborough, Inc. K221925
Sepsis SeptiCyte LAB Immunexpress, Inc. K163260
Staphylococcus BD Max MRSA Assay BD Diagnostics (GeneOhm Sciences Canada, Inc.) K120138
Sepsis Staphylococcus QuickFISH BC AdvanDx, Inc. K113371
Staphylococcus Staphylococcus / MRSA Control Material MRSA/SA ELITe MGB EliTechGroup Epoch Biosciences. K112937
K132468
Staphylococcus Staphylococcus / MRSA Control Material Verigene Staphylococcus Blood Culture (BC-S) Nucleic Acid Test Nanosphere, Inc. K112424
Staphylococcus Staphylococcus / MRSA Control Material NucliSENS EasyQ MRSA Assay bioMerieux, Inc. K102740
Staphylococcus Staphylococcus / MRSA Control Material Xpert MRSA/SA Blood Culture Assay Cepheid K101879
K082140
Staphylococcus Staphylococcus / MRSA Control Material Xpert MRSA/SA Nasal Complete Assay Cepheid K100822
Staphylococcus Staphylococcus / MRSA Control Material LightCycler MRSA Advanced Test Roche Molecular Systems, Inc K091409
Staphylococcus Staphylococcus / MRSA Control Material BD GeneOhm MRSA ACP Assay BD Diagnostics (GeneOhm Sciences Canada, Inc.) K093346
Staphylococcus Staphylococcus / MRSA Control Material S. aureus and/or other Staphylococcus species PNA FISH Culture AdvanDx, Inc. K092166
Staphylococcus Staphylococcus / MRSA Control Material Xpert MRSA/SA SSTI Assay Cepheid K080837
Staphylococcus Staphylococcus / MRSA Control Material BD GeneOhM StaphSR Assay BD Diagnostics (GeneOhm Sciences Canada, Inc.) K071026
Staphylococcus Staphylococcus / MRSA Control Material S. aureus PNA FISH AdvanDx, Inc. K091827
K060099
Staphylococcus Staphylococcus / MRSA Control Material Xpert MRSA Cepheid K070462
Staphylococcus Staphylococcus / MRSA Control Material IDI-MRSA Assay Infectio Diagnostic, Inc. K042357
K033415
Staphylococcus Staphylococcus / MRSA Control Material MECA XPRESSFISH ADVANDX INC. K140619
Staphylococcus Staphylococcus / MRSA Control Material COBAS MRSA/SA TEST ROCHE MOLECULAR SYSTEMS INC. K142721
Staphylococcus Staphylococcus / MRSA Control Material Xpert MRSA NxG Cepheid K162444
Staphylococcus Staphylococcus / MRSA Control Material Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System Cepheid K190771
Staphylococcus Staphylococcus / MRSA Control Material Cepheid Xpert MRSA NxG Control Panel Microbiologics, Inc. K191172
Staphylococcus Staphylococcus / MRSA Control Material Cepheid Xpert SA Nasal Complete Control Panel Microbiologics, Inc. K191168
Streptococci ARIES GBS Assay Luminex Corporation K162772
Streptococci Xpert GBS LB Assay Cepheid K121539
Streptococci Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System Cepheid K203429
Streptococci Xpert Xpress GBS, GeneXpert Dx System, GeneXpert Infinity Systems Cepheid K222638
Streptococci illumigene Group A Streptococcus (GBS) DNA Amplification Assay Meridian Bioscience, Inc. K122019
Streptococci illumigene Group B Streptococcus (GBS) DNA Amplification Assay Meridian Bioscience, Inc. K121044
Streptococci BD Max GBS Assay Becton, Dickinson, & Co. K111860
Streptococci Cepheid Smart GBS Assay Cepheid K062948
Streptococci Xpert GBS Cepheid K060540
Streptococci IDI-Strep B Assay Infectio Diagnostic, Inc. K022504
Streptococci Gen-Probe Accuprobe Group B Streptococcus culture identification kit Chugai Pharmaceuticals Co, Ltd. K974572
Streptococci Accuprobe Streptococcus pneumoniae culture confirmation Gen-Probe, Inc. K902908
Streptococci ILLUMIGENE GROUP B STREPTOCOCCUS (GBS) DNA AMPLIFICATION ASSAY MERIDIAN BIOSCIENCE, INC. K112125
Streptococci AMPLIVUE GBS ASSAY QUIDEL CORPORATION K133503
Streptococci LYRA DIRECT STREP ASSAY QUIDEL CORPORATION K133883 (DEN140005)
Streptococci AMPLIVUE GAS ASSAY QUIDEL CORPORATION K141173
Streptococci LIAT STREP A ASSAY IQUUM INC K141338
Streptococci revogene GenePOC Inc. K170558
Streptococci GenePOC GBS LB GenePOC Inc. K170557
Streptococci Solana Strep Complete Assay Quidel Corporation K162274
Streptococci ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit Luminex Corporation K172402
Streptococci Xpert Xpress Strep A Cepheid K172126
K173398
Streptococci GenePOC Strep A GenePOC Inc. K183366
Streptococci / GBS Control 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
Trichomonas vaginalis Amplivue Trichomonas Assay Quidel Corporation K143329
Trichomonas vaginalis APTIMA Trichomonas vaginalis (ATV) Assay Gen-Probe, Inc. K102911
Trichomonas vaginalis APTIMA Trichomonas vaginalis Assay (PANTHER System) Gen-Probe, Inc. K122062
K231316
Trichomonas vaginalis BD ProbeTec Trichomonas vaginalis (TV) QX Amplified DNA Assay Becton, Dickinson & Co. K130268
Trichomonas vaginalis Solana Trichomonas Assay Quidel Corporation K161182,
K161182/S001
Trichomonas vaginalis Xpert TV Cepheid K151565
K151565/S001,
K161619
Trichomonas vaginalis Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit Hologic, Inc. K200436
Transport Media PRIMESTORE MTM Longhorn Vaccines and Diagnostics LLC DEN170029
Vaginal Panel (Bacterial vaginosis vaginitis) BD Vaginal Panel Becton, Dickinson And Company K223653
Vaginal Panel (Bacterial vaginosis vaginitis) BD MAX Vaginal Panel GeneOhm Sciences Canada, Inc. (BD Diagnostics) DEN160001
Vaginal Panel (Bacterial vaginosis vaginitis) BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit GeneOhm Sciences Canada, Inc. (BD Life Sciences) K201017
Vaginal Panel (Bacterial vaginosis vaginitis) Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System Cepheid K212213
K221160
K231381
Varicella-zoster viruses Simplexa VZV Direct, Simplexa VZV Positive Control Pack DiaSorin K192376
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
 
Back to Top