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 | Shield | Guardant Health, Inc. | P230009 |
| 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 | PGDx elio plasma focus Dx | Personal Genome Diagnostics, Inc. | DEN230046 |
| Tumor Profiling | TruSight Oncology Comprehensive | Illumina, Inc. | P230011 |
| 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 |
| Fungal Pathogen Panel | LIAISON PLEX Yeast Blood Culture Assay | Luminex Corporation | K240627 |
| 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 |
| Hepatitis virus | Xpert HCV; GeneXpert Xpress System | Cepheid | DEN240016 |
| 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 |
LIAISON PLEX Respiratory Flex (RSP Flex) Assay | Luminex Corporation | K233410 |
| 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 K241240 |
| 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 |
| SARS-CoV2-respiratory infection and other microbial agents | Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit | Life Technologies Corporation | K233453 |
| 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 |