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 |
Vysis EGR1 FISH Probe Kit | Abbott Molecular Inc. | K123951,K091960 | |
LeukoStrat CDx FLT3 Mutation Assay | INVIVOSCRIBE TECHNOLOGIES, INC | P160040 | |
Abbott RealTime IDH2 | ABBOTT MOLECULAR, INC. | P170005 | |
Abbott RealTime IDH1 | ABBOTT MOLECULAR, INC. | P170041 | |
Acute Myeloid Leukemia or Myelodysplastic Syndrome | VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION | ABBOTT MOLECULAR, INC. | DEN130010 |
Aggressive Systemic Mastocytosi | KIT D816V ASSAY | ARUP LABARATORIES | H140006 |
Autosomal Recessive Carrier Screening | 23ANDME PERSONAL GENOME SERVICE | 23andMe | DEN140044 |
B-cell chronic lymphocytic leukemia | VYSIS CLL FISH PROBE KIT | ABBOTT MOLECULAR, INC | K100015 |
VYSIS CLL FISH PROBE KIT | ABBOTT MOLECULAR, INC | P150041 | |
CEP 12 SpectrumOrange Direct Labeled Chromosome Enumeration DNA Probe | Vysis | K962873 | |
Bladder Cancer | Vysis UroVysion Bladder Cancer Recurrence Kit | Vysis | K033982, K013785, K011031 |
Breast Cancer | 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) | 23andMe | DEN170046 |
Prosigna Breast Cancer Prognostic Gene Signature Assay | Nanostring Technologies | K130010 | |
MammaPrint | Agendia BV | K101454, K081092, K080252, K070675, K062694 | |
INFORM HER2 Dual ISH DNA Probe Cocktail | Ventana Medical Systems, Inc. | P100027 | |
HER2 CISH pharmDxTM Kit | Dako Denmark A/S | P100024 | |
HER2 Dual ISH DNA Probe Cocktail | Ventana Medical Systems, Inc. | P190031 | |
GeneSearch Breast Lymph Node (BLN) Test Kit | Veridex, LLC. | P060017 S001-S004 | |
Dako TOP2A FISH PharmDx Kit | Dako Denmark A/S | P050045 S001-S004 | |
HER2 IQFISH PHARMDX | DAKO DENMARK A/S | P040005 | |
INSITE HER-2/NEU KIT | BIOGENEX LABORATORIES, INC. | P040030 | |
SPOT-LIGHT HER2 CISH KIT | INVITROGEN CORPORATION | P050040 | |
INFORM HER-2/NEU | VENTANA MEDICAL SYSTEMS, INC. | P940004 | |
DAKO HERCEPTEST | DAKO A/S | P980018 | |
PATH VYSION HER-2 DNA PROBE KIT | ABBOTT MOLECULAR, INC. | P980024 | |
DakoCytomation Her2 FISH pharmDx™ Kit | DakoCytomation Denmark A/S | P040005 | |
Therascreen PIK3CA RGQ PCR Kit | QIAGEN GMBH | P190001 | |
Therascreen PIK3CA RGQ PCR Kit | QIAGEN GMBH | P190004 | |
Cell-free DNA blood collection device | Cell-Free DNA BCT | Streck, Inc. | DEN200001 |
Chromosome abnormalities | Affymetrix CytoScan Dx Assay | Affymetrix, Inc. | K130313 |
AneuVysion | Vysis | K010288, K972200 | |
CYTOSCAN(R) DX | Affymetrix, Inc. | DEN130018 | |
GenetiSure Dx Postnatal Assay | Agilent Technologies, Inc. | K163367 | |
CEP 8 Spectrumorange DNA Probe Kit | Vysis | K953591 | |
CEP X SpectrumOrange/ Y SpectrumGreen DNA Probe Kit | Vysis | K954214 | |
Chronic Myeloid Leukemia | Quantidex qPCR BCR-ABL IS Kit | ASURAGEN, INC. | DEN160003 |
Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s And GeneXpert Infinity-80 Systems | Cepheid | K190076 | |
QXDx BCR-ABL %IS Kit For Use On The QXDx AutoDG DdPCR System | Bio-Rad Laboratories, Inc. | K181661 | |
MRDx BCR-ABL Test, MRDx BCR-ABL Test Software | MolecularMD Corporation | K173492 | |
Coagulation Factors | Invader Factor V | Hologic, Inc. | K100980 |
Invader Factor II | Hologic, Inc. | K100943 | |
Illumina VeraCode Genotyping Test for Factor V and Factor II | Illumina, Inc. | K093129 | |
eSensor Thrombophilia Risk Test, eSensor FII-FV Genotyping Test, eSensor Fll Genotyping Test, eSensor FV Genotyping Test, eSensor MTHFR Genotyping Test | Osmetech Molecular Diagnostics | K093974 | |
Xpert HemosIL FII & FV | Cepheid | K082118 | |
Verigene F5 Nucleic Acid Test Verigene F2 Nucleic Acid Test Verigene MTHFR Nucleic Acid Test |
Nanosphere, Inc. | K070597 | |
INFINITI System | Autogenomics, Inc. | K060564 | |
Factor II (Prothrombin) G20210A Kit | Roche Diagnostics Corporation | K033612 | |
Factor V leiden Kit | Roche Diagnostics Corporation | K033607 | |
Invader MTHFR 677 | Hologic, Inc. | K100987 | |
Invader MTHFR 1298 | Hologic, Inc. | K100496 | |
COAGULATION, LATE-ONSET ALHEIMER'S DISEASE, PARKINSON'S DISEASE, CELIAC DISEASE, ALPHA-1 ANTITRYPSIN DEFICIENCY, EARLY-ONSET PRIMARY DYSTONIA, FACTOR IX DEFICIENCY, GAUCHER DISEASE TYPE 1, GLUCOSE-6-PHOPHATE DEHYDROGENASE DEFICIENCY, HERDITARY HEMOCHROMATOSIS, HEREDITARY THROMBOPHILIA | PERSONAL GENOME SERVICE (PGS) GENETIC HEALTH RISK TEST FOR HEREDITARY THROMBOPHILIA | 23andME | DEN160026 |
Health Risk Assessment System | AncestryDNA Factor V Leiden Genetic Health Risk Test | Ancestry Genomics, Inc. | K192944 |
Colorectal Cancer | Cologuard | Exact Sciences Corporation | P130017 |
Therascreen KRAS RGQ PCR Kit | QIAGEN MANCHESTER LTD | P110027/P110030 | |
Therascreen BRAF V600E RGQ PCR Kit | QIAGEN MANCHESTER LTD | P190026 | |
Epi ProColon® | Epigenomics AG | P130001 | |
Cobas KRAS MUTATION TEST | Roche Molecular Systems, Inc. | P140023 | |
Praxis Extended RAS Panel | Illumina, Inc. | P160038 | |
VENTANA ANTI-MLH-1(M1) MOUSE MONOCLONAL PRIMARY ANTIBODY, VENTANA ANTI-PMS2 (A16-4) MOUSE MONOCLONAL PRIMARY ANTIBODY, VENTANA ANTI-MSH2 (G219-1129) MOUSE MONOCLONAL PRIMARY ANTIBODY, VENTANA ANTI-MSH6 (SP 93) MOUSE MONOCLONAL PRIMARY ANTIBODY, VENTANA ANTI-BRAF V600E (VE1) MOUSE MONOCLONAL PRIMARY ANTIBODY | Ventana Medical Systems | DEN170030 | |
Colorectal Cancer Predisposition | MUTYH-Associated Polyposis (MAP) | 23andMe | K182784 |
Cystic Fibrosis | Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay | Illumina, Inc | K132750 |
Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay | Illumina, Inc | K124006 | |
xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR | Luminex Molecular Diagnostics, Inc. | K163336 | |
xTAG Cystic Fibrosis 39 Kit v2 | Luminex Molecular Diagnostics, Inc. | K163347 | |
eSensor CF Genotyping Test | Osmetech Molecular Diagnostics | K090901 | |
xTAG Cystic Fibrosis 60 Kit v2 | Luminex Molecular Diagnostics Inc. | K083845 | |
xTAG Cystic Fibrosis 39 Kit v2 | Luminex Molecular Diagnostics Inc. | K083846 | |
Verigene CFTR and Verigene CFTR PolyT Nucleic Acid Tests | Nanosphere, Inc | K083294 | |
InPlex CF Molecular Test | Third Wave Technology, Inc. | K063787 | |
Cystic Fibrosis Genotyping Assay | Celera Diagnostics | K062028 | |
Tag-It Cystic Fibrosis Kit | Tm Bioscience Corporation | K060627, K043011 | |
eSensor Cystic Fibrosis Carrier Detection System | Clinical Micro Sensors, Inc. | K060543, K051435 | |
Drug Metabolizing enzymes |
xTAG CYP2D6 Kit v3 | Luminex Molecular Diagnostics, Inc. | K130189, K093420 |
xTAG CYP2D6 Kit v3 | Luminex Molecular Diagnostics, Inc. | K130189, K131565 | |
Spartan RX CYP2C19 Test System | Akonni Biosystems Inc. | K183530 | |
TruDiagnosis System | Akonni Biosystems Inc | K183530 | |
Verigene CYP2C 19 Nucleic Acid Test | Nanosphere, Inc. | K120466 | |
INFINITI CYP2C19 Assay | AutoGenomics, Inc. | K101683 | |
Invader UGT1A1 Molecular Assay | Third Wave Technologies Inc. | K051824 | |
Roche AmpliChip CYP450 microarray | Roche Molecular Systems, Inc. | K043576, K042259 | |
eSensor Warfarin Sensitivity Saliva Test | GenMark Diagnostics | K110786 | |
eQ-PCR LC Warfarin Genotyping kit | TrimGen Corporation | K073071 | |
eSensor Warfarin Sensitivity Test and XT-8 Instrument | Osmetech Molecular Diagnostics | K073720 | |
Gentris Rapid Genotyping Assay - CYP2C9 & VKORCI | ParagonDx, LLC | K071867 | |
INFINITI 2C9 & VKORC1 Assay for Warfarin | AutoGenomics, Inc. | K073014 | |
Verigene Warfarin Metabolism Nucleic Acid Test and Verigene System | Nanosphere, Inc. | K070804 | |
Endometrial Cancer | VENTANA MMR RxDx | Ventana Medical Systems, Inc. | P200019 |
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 |
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 | xSeptiCyte RAPID | Immunexpress, Inc | K203748 |
Non-Small Cell Lung Cancer | VYSIS ALK BREAK APART FISH PROBE KIT | ABBOTT MOLECULAR, INC. | P110012 |
Cobas EGFR MUTATION TEST v2 | Roche Molecular Systems, Inc. | P120019 | |
THERASCREEN EGFR RGQ PCR KIT | QIAGEN MANCHESTER LTD | P120022 | |
Cobas EGFR MUTATION TEST v2 | Roche Molecular Systems, Inc. | P150044 | |
Cobas EGFR MUTATION TEST v2 | Roche Molecular Systems, Inc. | P150047 | |
Oncomine Dx Target Test | LIFE TECHNOLOGIES CORPORATION | P160045 | |
Ovarian Cancer | BRACAnalysis CDx | Myriad Genetic Laboratories, Inc. | P140020 |
FoundationFocus CDxBRCA | FOUNDATION MEDICINE, INC | P160018 | |
Pharmacogenetic Reports | 23ANDME PERSONAL GENOME SERVICE (PGS) PHARMACOGENETIC REPORTS | 23andMe | DEN180028 |
Pharmacogenetic Reports | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | 23andMe, Inc. | K193492 |
Platforms, Imaging Systems, and Reagents | ILLUMINA MISEQDX PLATFORM | Illumina, Inc | DEN130011 |
MISEQDX UNIVERSAL KIT 1.0 | Illumina, Inc. | DEN130042 | |
DUET SYSTEM | BIOVIEW LTD. | K130775 | |
Prostate Cancer | NADiA ProsVue | Iris Molecular Diagnostics | K101185 |
PROGENSA PCA3 Assay | Gen-Probe, Inc. | P100033 | |
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 |
Saliva DNA Specimen Collection Device | AncestryDNA Saliva Collection Kit | Ancestry Genomics, Inc. | K192947 |
Tissue of Origin | Pathwork Tissue of Origin Test Kit – FFPE | Pathwork Diagnostics Inc. | K120489, K092967 |
Pathwork Tissue of Origin Test | Pathwork Diagnostics Inc. | K080896 | |
Tissue of Origin Test Kit - FFPE | Cancer Genetics, Inc. | K173839 | |
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 |
FoundationOne CDx | Foundation Medicine, Inc. | P170019 | |
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 |
---|---|---|---|
Adenovirus | Adenovirus R-gene US | Argene SA | K121942 |
Lyra Adenovirus Assay | Quidel Corportation | K141931 | |
ProAdeno+ Assay | Gen-Probe Prodesse, Inc. | K102952 | |
Prodesse ProAdeno + Assay | Gen-Probe Prodesse, Inc. | K132159 | |
Antimicrobial resistance | GenePOC Carba | GenePOC Inc. | K190275 |
Antimicrobial resistance | Accelerate Pheno System, Accelerate PhenoTest BC Kit | Accelerate Diagnostics, Inc. | K192665 |
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 |
AMPLIVUE BORDETELLA ASSAY | QUIDEL CORPORATION | K143206 | |
Great Basin Bordetella Direct Test | Great Basin Scientific, Inc. | K170284 | |
ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT ILLUMIPRO-10 AUTOMATED ISOTHERMA | MERIDIAN BIOSCIENCE, INC. | K133673, K152285 | |
SIMPLEXA BORDETELLA DIRECT, SIMPLEXA BORDETELLA POSITIVE CONTROL PACK | DIASORIN MOLECULAR LLC | K173498 | |
SIMPLEXA BORDETELLA DIRECT, SIMPLEXA BORDETELLA POSITIVE CONTROL PACK | DIASORIN MOLECULAR LLC | K183223 | |
Candida tropicalis / Candida albicans / Candida parapsilosis / Candida glabrata / Candida krusei | Affirm VPIII Microbial Identification Test | Microprobe Corp. | K931151, K931374 |
Yeast Traffic Light PNA FISH | AdvanDx, Inc. | K093024, K080719 | |
C. albicans / C. glabrata PNA FISH | AdvanDx, Inc. | K092784 | |
C. albicans PNA FISH | AdvanDx, Inc. | K092655, K062461 | |
C. Albicans screen | Carr-Scarborough Microbiologicals, Inc. | K891476 | |
T2Candida 1.1 Panel | T2 Biosystems, Inc. | K173536 | |
Candida glabrata / Candida species group / Trichomonas vaginalis (TV) |
Aptima CV/TV Assay | Candida glabrata / Candida species group / Trichomonas vaginalis (TV) |
K190472 |
Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis | BD CTGCTV2 | Becton Dickinson and Company | K210585 |
Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and Mycoplasma genitalium | Alinity m STI Assay | Abbott Molecular, Inc. | K202977 |
Clostridium difficile | ARIES C. difficile Complete Kit, ARIES C. difficile Assay Protocol File Kit | Luminex | K171441 |
Solana C. difficile Assay | Quidel Corporation | K170491 | |
ICEPlex C. difficile Kit | PrimeraDx | K132726 | |
IMDx C. difficile for Abbott m2000 | Intelligent Medical Devices, Inc. | K132235 | |
BD Diagnostics BD MAX Cdiff Assay | GeneOhm Sciences Canada Inc. | K130470 | |
Quidel Molecular Direct C. difficile Assay | Quidel Corporation | K123998 | |
Verigene C. Difficile Nucleic acid Test | Nanosphere, Inc. | K123197 | |
Portrait Toxigenic C. difficile Assay | Great Basin Scientific, Inc. | K113358 | |
Simplexa C. difficile Universal Direct Assay | Focus Diagnostics, Inc. | K113433, K163085, K163085/S001 | |
Xpert C. difficile/Epi | Cepheid | K110203 | |
Illumigene C. difficile DNA Amplification Assay | Meridian Bioscience, Inc. | K110012 | |
Illumigene C. difficile Assay | Meridian Bioscience, Inc. | K100818, K110012 | |
Xpert C. difficile | Cepheid | K091109 | |
ProGastro Cd Assay | Prodesse Inc. | K090239 | |
BD GeneOhm C. diff Assay | BD Diagnostics/ GeneOhm Sciences, Inc. | K081920 | |
ARTUS C. DIFFICILE QS-RGQ MDX KIT | QIAGEN, GMBH | K133936 | |
AMPLIVUE C. DIFFICILE ASSAY | QUIDEL CORPORATION | K123355 | |
GenePOC CDiff | GenePOC Inc | K172569 | |
Cobas Cdiff Nucleic Acid Test For Use On The Cobas Liat System | Roche Molecular Systems, Inc. | K171770 | |
Clostridium difficile QC material | Cepheid Xpert C. Difficile/Epi Control Panel | Microbiologics, Inc. | K190463 |
Clostridium difficile Toxin Gene | Cobas Cdiff nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc | K210385 |
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 | Abbott Molecular Inc. | K092704, K080739 |
Accuprobe Neisseria gonorrhoeae Culture Confirmation Test | Gen-Probe, Inc. | K895583 | |
Amplicor Chlamydia trachomatis Test | Roche Molecular Systems, Inc. | K922906 | |
AMPLICOR CT/NG Test for Chlamydia trachomatis | Roche Molecular Systems, Inc. | K973707 | |
AMPLICOR CT/NG test for Chlamydia trachomatis | Roche Diagnostics Corp. | K070174 | |
AMPLICOR CT/NG test for Neisseria gonorrhoeae | Roche Diagnostics Corp. | K070172 | |
APTIMA Combo 2 Assay | Gen-Probe, Inc. | K111409 | |
APTIMA Combo 2 Assay (Panther System) | Hologic/Gen-Probe, Inc. | K132251 | |
BD MAX CT/GC/TV, BD MAX Instrument | Becton, Dickinson, & Co. | K151589, K151589/S001, K151589/S002 | |
BD ProbeTec Chlamydia trachomatis (CT) Qx Amplified DNA Assay | Becton, Dickinson, & Co. | K091724, K090824, K081824 | |
BD Probetec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay | Becton, Dickinson, & Co. | K091730, K090971, K090827, K081825 | |
BD ProbeTec Chlamydia trachomatis (CT) Qx Amplified DNA Assay on the BD Viper LT System | Becton, Dickinson, & Co. | K140446 | |
BD Probetec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay on the BD Viper LT System | Becton, Dickinson, & Co. | K140048 | |
BDProbeTec ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays | Becton Dickinson Microbiology Systems | K984631 | |
BDProbeTec ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays | Becton, Dickinson, & Co. | K012351 | |
binx health io CT/NG Assay | binx health, Inc. | K191352 | |
COBAS 4800 CT/NG Test | Roche Molecular Systems, Inc. | K110923 | |
COBAS AMPLICOR CT/NG test for Chlamydia trachomatis | Roche Molecular Systems, Inc. | K973718 | |
COBAS AMPLICOR CT/NG test for Chlamydia trachomatis | Roche Diagnostics Corp. | K053287 | |
COBAS AMPLICOR CT/NG test for Neisseria gonorrhoeae | Roche Molecular Systems, Inc. | K974342 | |
COBAS AMPLICOR CT/NG test for Neisseria gonorrhoeae | Roche Diagnostics Corp. | K053289 | |
COBAS CT/NG FOR USE ON COBAS 6800/8800 SYSTEMS | Roche Molecular Systems, Inc. | K173887 | |
cobas CT/NG v2.0 Test | Roche Molecular Systems, Inc. | K132270, K140887, K163184 | |
cobas CTNG for use on cobas 6800/8800 systems | Roche Molecular Systems, Inc. | K202408 | |
GEN-PROBE AMPLIFIED Chlamydia trachomatis Assay Kit | Gen-Probe, Inc. | K962217 | |
GEN-PROBE APTIMA Assay for Neisseria gonorrhoeae | Gen-Probe, Inc. | K063664, K062440, K043144 | |
GEN-PROBE APTIMA Assay for Chlamydia trachomatis | Gen-Probe, Inc. | K063451, K053446, K043072 | |
GEN-PROBE APTIMA Combo 2 Assay | Gen-Probe, Inc. | K043224, K032554, K003395 | |
GEN-PROBE PACE 2C System for Chlamydia trachomatis and Neisseria gonorrhoeae | Gen-Probe, Inc. | K940979 | |
GONOSPOT DNA Probe Culture Confirmation Test | Ortho Diagnostic Systems, Inc. | K872628 | |
GONOSTAT Gonococcal Detection Kit | Sierra Diagnostics, Inc. | K991268 | |
Hybrid Capture II CT/GC Test | Digene Corp. | K981567, K010891 | |
Hybrid Capture II CT-ID Test | Digene Corp. | K990023, K010892 | |
Hybrid Capture II GC-ID Test | Digene Corp. | K981485, K010893 | |
LCx Chlamydia trachomatis Assay | Abbott Laboratories | K934622 | |
LCx Neisseria gonorrhoeae Assay | Abbott Laboratories | K935833 | |
PACE 2 Chlamydia trachomatis probe confirmation assay | Gen-Probe, Inc. | K920302 | |
PACE 2 Neisseria gonorrhoeae probe confirmation assay | Gen-Probe, Inc. | K920301 | |
PACE 2 System for Chlamydia trachomatis | Gen-Probe, Inc. | K920378 | |
GEN-PROBE PACE System for Chlamydia trachomatis | Gen-Probe, Inc. | K874878 | |
GEN-PROBE System for Neisseria gonorrhoeae | Gen-Probe, Inc. | K874620 | |
PACE System for Neisseria gonorrhoeae | Gen-Probe, Inc. | K881277 | |
Rapid Diagnostic System for Chlamydia trachomatis | Gen-Probe, Inc. | K871878 | |
Roche AMPLICOR CT/NG test for Neisseria gonorrhoeae | Roche Molecular Systems, Inc. | K974503 | |
Roche COBAS AMPLICOR Chlamydia trachomatis test | Roche Molecular Systems, Inc. | K964507 | |
TIGRIS DTS Automated Analyzer APTIMA Assay for Chlamydia trachomatis | Gen-Probe, Inc. | K061413 | |
TIGRIS DTS GEN-PROBE APTIMA Assay for Neisseria gonorrhoeae | Gen-Probe, Inc. | K061509 | |
TIGRIS DTS GEN-PROBE APTIMA COMBO 2 Assay | Gen-Probe, Inc. | K060652 | |
Xpert CT/NG | Cepheid | K121710 | |
Xpert CT/NG | Cepheid | K190441 | |
Aptima Combo 2 Assay (Panther System) | Hologic, Inc. | K190515 | |
Aptima Combo 2® Assay (Panther® System) Aptima Combo 2® Assay (Tigris® DTS® System) |
Hologic, Inc. | K200866 | |
binx io CT/NG Assay and binx io CT/NG System | binx health Inc | K200533 | |
CT/GC/TV QC material | BD MAX CT/GC/TV 20-DAY QC PANEL | MICROBIOLOGICS, INC. | K181683 |
CT/GC QC material | Cepheid Xpert CT/NG Control Panel | Microbiologics, Inc. | K190223 |
Cytomegalovirus | Abbott RealTime CMV | Abbott Molecular | P160044 |
ARTUS CMV RGQ MDX Kit | QIAGEN | P130027 | |
Alinity M CMV | Abbott Molecular, Inc. | P210022 | |
Aptima CMV Quant Assay | Hologic, Inc. | P210029 | |
COBAS AmpliPrep/COBAS TaqMan CMV Test | Roche Molecular Systems | P110037 | |
COBAS CMV Test | Roche Molecular Systems | P160041 | |
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 |
Entercoccus | IMDx Van R for Abbott m2000 | Intelligent Medical Devices, Inc. | K123753 |
BD GeneOhm VanR Assay | BD Diagnostics (GeneOhm Sciences, Inc.) | K102416 | |
Xpert vanA Assay | Cepheid | K092953 | |
E. faecalis/OE PNA | AdvanDx, Inc. | K083074 | |
GBS PNA FISH | AdvanDx, Inc. | K082612 | |
E. faecalis PNA FISH culture identification kit | AdvanDx, Inc. | K063127 | |
Enteric parasite QC material | BD MAX ENTERIC PARASITE CONTROL PANEL, BD MAX ENTERIC PARASITE 20-DAY QC PANEL | MICROBIOLOGICS, INC. | K181711 |
Enterovirus | NucliSens EasyQ Enterovirus vl.1 Assay | bioMérieux, Inc. | K093383, K063261 |
Escherichia coli / Klebsiella pneumoniae / Pseudomonas aeroginosa | GNR Traffic Light PNA FISH | AdvanDx, Inc. | K101558 |
E. coli/P. aeruginosa PNA FISH | AdvanDx, Inc. | K092236, K081309 | |
EK/P aeruginosa PNA FISH | AdvanDx, Inc. | K092393, K081433 | |
E. coli PNA FISH | AdvanDx, Inc. | K082068 | |
Francisella tularensis | JBAIDS Tularemia Detection Kit | Idaho Technology, Inc. | K072547 |
Fungal Pathogen Panel | EPLEX BLOOD CULTURE IDENTIFICATION PANEL FUNGAL PATHOGEN (BCID-FP) PANEL | GENMARK DIAGNOSTICS, INCORPORATED | K182690 |
Gram-Positive / Gram-Negative Bacteria | Accelerate Pheno System, Acceleraet Phenotest BC Kit | Accelerate Diagnostics | DEN160032, DEN160032/S001 |
Great Basin Staph ID/R Blood Culture Panel | Great Basin Scientific, Inc. | K152470, K152470/S001 | |
hemoFISH Masterpanel | Miacom Diagnostics GMBH | K150031, K150031/S001 | |
IC-GPC Assay for use on the IC-System (positive blood cultures) | iCubate, Inc. | K163390, K163390/S001 | |
Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) | Nanosphere, Inc. | K122514, K113450 | |
Xpert Carba-R (GNR) | Cepheid | K152614, K152614/S001, K160901 (Rectal Swabs) | |
EPLEX BLOOD CULTURE IDENTIFICATION PANEL - GRAM POSITIVE (BCID-GP) PANEL | GENMARK DIAGNOSTICS, INCORPORATED | K181663 | |
EPlex Blood Culture Identification Gram Negative (BCID-GN) Panel | GenMark Diagnostics, Incorporated | K182619 | |
IC-GN IC-Cassette For Use On The IC-System | ICubate, Inc. | K190341 | |
Gram-Positive / Gram-Negative Bacteria (Antimicrobial resistance) | XPERT CARBA-R | CEPHEID | K173263 |
Herpes Simplex Virus | Aptima Herpes Simpex Viruses 1 & 2 | Hologic, Inc. | K162673, K162673/S001 |
ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit | Luminex Corporation | K151906 | |
ARIES System | Luminex Corporation | K160517, K160517/S001 | |
ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD) | Luminex Corporation | K161495 | |
IsoAmp HSV Assay | BioHelix Corporation | K111951 | |
MultiCode-RTx Herpes Simplex Virus 1 & 2 Kit | EraGen Biosciences, Inc. | K111527, K100336 | |
BD ProbeTec Herpes Simplex Viruses (HSV I & 2) QX Amplified DNA Assays | BD Diagnostic Systems | K103798 | |
SIMPLEXA HSV 1&2 DIRECT | FOCUS DIAGNOSTICS | K133621 (DEN130049) | |
AMIPLIVUE HSV 1&2 ASSAY | QUIDEL CORPORATION | K140029 | |
IMDX HSV-1/2 FOR ABBOTT M2000 | INTELLIGENT MEDICAL, INC. | K140198 | |
SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK | FOCUS DIAGNOSTICS | K141458, K151565, K151565/S001 | |
SIMPLEXA HSV 1 & 2 DIRECT, SIMPLEXA HSV 1 & 2 Positive Control Pack | DIASORIN MOLECULAR LLC | K173798 | |
Solana HSV 1+2/VZV Assay | Quidel Corporation | K162451 | |
ARTUS HSV-1/2 QS-RGQ MDx KIT | QIAGEN | K142738 | |
SEEGENE ANYPLEX II HSV-1/2 ASSAY | SEEGENE | K142156 | |
QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY | DIAGNOSTIC HYBRIDS INC. | K133448 (DEN140004) | |
SENTOSA SA201 HSV 1/2 QUALITATIVE PCR TEST | VELA DIAGNOSTICS USA INC. | K172509 | |
HSV 1 & 2 ELITE MGB KIT; ELITE INGENIUS | ELITECHGROUP | K180559 | |
Hepatitis virus | Abbott RealTime HCV Genotype II | Abbott Molecular, Inc. | P120012 S001-S0016 |
Abbott Realtime HCV Assay | Abbott Molecular, Inc. | P100017 S001-S006, S007-S012, S014-S019 | |
Alinity m HCV | Abbott Molecular, Inc. | P190025 | |
Abbott Realtime HBV Assay | Abbott Molecular, Inc. | P080026 S001-S004, S005-S014, S016-S020 | |
Aptima HCV Quant Dx Assay | Hologic, Inc. | P160023 | |
COBAS HBV Test | Roche Molecular Systems | P150014 S001-S008 | |
Alinity m HBV | Abbott Molecular, Inc. | P200013 | |
COBAS HCV Test | Roche Molecular Systems | P160016 | |
COBAS HCV Test | Roche Molecular Systems | P150015 S001-S007 | |
COBAS AmpliPrep/COBAS TaqMan HCV test | Roche Molecular Systems | P060030 S001-S032, S033-S047, S048-S058 | |
COBAS Taqman HBV Test | Roche Molecular Systems, Inc. | P050028 S001-S027, S028-S047, S048, S050-S057 | |
Versant HCV 3.0 Assay (bDNA) | Siemens Healthcare Diagnostics | P020022 | |
Versant HCV RNA Qualitative Assay | Gen-Probe, Inc. | P020011 S001-S007, S008, S009 | |
COBAS AMPLICOR Hepatitis C Virus (HCV) Test | Roche Molecular Systems, Inc. | P000012 S001-S043, S044-S053, S054-S056 | |
AMPLICOR HCV Test, v2.0 | Roche Molecular Systems, Inc. | P000010 S001-S024 | |
APTIMA HBV QUANT ASSAY | HOLOGIC, INC | P170025 | |
Human Metapneumovirus | Pro hMPV+ Assay | Gen-Probe Prodesse, Inc. | K132200, K082688, K123838 |
Quidel Molecular hMPV Assay | Quidel Corporation | K112490 | |
Quidel Molecular RSV + hMPV Assay | Quidel Corporation | K131813, K122189 | |
Human Papillomvirus | APTIMA HPV 16 18/45 Genotype Assay | Gen-Probe, Inc. | P120007 S001-S010 |
APTIMA HPV Assay | Gen-Probe, Inc. | P100042 S001-S012 | |
BD ONCLARITY HPV ASSAY | BECTON, DICKINSON AND COMPANY | P160037 | |
cobas HPV for use on the cobas 6800/8800 Systems | Roche Molecular Systems, Inc |
P190028 | |
Cervista HPV 16/18 | Hologic, Inc. | P080015;S001-S012 | |
Cervista HPV HR and Genfind DNA Extraction Kit | Hologic, Inc. | P080014 S001-S018 | |
COBAS HPV Test | Roche Molecular Systems, Inc. | P100020 S001-S024 | |
Digene Hybrid Capture 2 High-Risk HPV DNA Test | Digene Corporation | P890064 S001-S034 | |
Influenza and Respiratory Viruses | PLEX-ID Flu assay | Abbott Laboratories | K121003 |
Alere i Influenza A & B | ALERE SCARBOROUGH, INC D/B/A BINAX, INC | K141520, K151464, K151690, K163266 | |
Alere i RSV | Alere Scarborough, Inc. | K161375 | |
ARIES Flu A/B & RSV Assay | Luminex Corporation | K161220 | |
artus Infl A/B RG RT-PCR Kit | Qiagen GmbH | K113323 | |
CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel | Centers for Disease Control and Prevention | K080570 | |
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel | Centers for Disease Control and Prevention | K133869, K132508, K130551, K123905, K111507, K161556 | |
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit | Centers for Disease Control and Prevention | K161556 | |
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit | Centers for Disease Control and Prevention | K172091 | |
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/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 | |
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL INFLUENZA A/H5 SUBTYPING | CENTERS FOR DISEASE CONTROL AND PREVENTION | K141859, K153148 | |
CDC Influenza 2009 A (H1N1) pdm Real-Time RT-PCR Panel | Centers for Disease Control and Prevention | K101564 | |
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel Influenza B Lineage Genotyping Kit | Centers for Disease Control and Prevention | K181736 | |
XPERT XPRESS FLU/RSV, XPERT Nasopharyngral Sample Collection Kit, XPERT Nasal Sample Collection Kit, GENEXPERT XPRESS II, GENEXPERT XPRESS IV | Cepheid | K180218 | |
ACCULA RSV TEST | MESA BIOTECH, INC. | K181443 | |
BioCode Respiratory Pathogen Panel (RPP) | Applied BioCode, Inc | K192485 | |
cobas Liat Influenza A/B & RSV | Iquum, Inc. | K153544, K153544/S001 | |
eNAT molecular collection and preservation medium | Copan Italia S.p.A. | K201849 | |
DNA/RNA Shield Collection Tube | Zymo Research | K202641 | |
ePlex Respiratory Pathogen Panel | GenMark Diagnostics, Inc | K163636, K163636/S001 | |
eSensor Respiratory Viral Panel (RVP) | Clinical Micro Sensors, Inc. | K113731 | |
FilmArray Respiratory Panel (RP) | Idaho Technology, Inc. | K120267, K110764, K103175 | |
FilmArray Respiratory Panel (RP) | BioFire Diagnostics, LLC | K123620, K143080, K160068 | |
FilmArray Respiratory Panel 2 (RP2) | BioFire Diagnostics, LLC | K170604 | |
FilmArray Respiratory Panel EZ (RP EZ) | BioFire Diagnostics, LLC | K152579, K152579/S001, K152579/S002 | |
FilmArray RP EZ Control Panel M265 | Maine Molecular Quality Controls, Inc. | K161573 | |
Idylla Respiratory (IFV-RSV) Panel | Janssen Pharmaceutica NV | K163628, K163629, K163630 | |
IMDx Flu A/B and RSV for Abbott m2000 | Intelligent Medical Devices, Inc. | K131584 | |
INFLUENZA A SUBTYPING KIT CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | CENTERS FOR DISEASE CONTROL AND PREVENTION | K140851 | |
Influenza A/H5 (Asian lineage) Virus Real-time RT-PCR Primer and Probe Set | Centers for Disease Control and Prevention | K060159 | |
INFLUENZA B LINEAGE GENOTYPING KIT CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | CENTERS FOR DISEASE CONTROL AND PREVENTION | K140857 | |
JBAIDS Influenza A Subtyping Kit | U.S. Army Medical Materiel Development Activity | K111778 | |
JBAIDS Influenza A&B Detection Kit | U.S. Army Medical Materiel Development Activity | K111775, K152523 | |
JBAIDS Influenza A/H5 (Asian lineage) Detection Kit | U.S. Army Medical Materiel Development Activity | K100287 | |
Liat Influenza A/B Assay | IQuum, Inc. | K111387 | |
LYRA PARAINFLUENZA VIRUS ASSAY | QUIDEL CORPORATION | K141927 | |
NxTAG Respiratory Pathogen Panel | Luminex Molecular Diagnostics, Inc. | K152386, K152386/S001 | |
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software | Luminex Molecular Diagnostics, Inc. | K193167 | |
Prodesse ProFAST Assay | Gen-Probe Prodesse, Inc. | K132237 | |
Prodesse ProFlu + Assay | Gen-Probe Prodesse, Inc. | K132129 | |
Prodesse ProParaflu Assay | Gen-Probe Prodesse, Inc. | K132238, K091053 | |
Prodesse ProParaflu Assay | Hologic/Gen-Probe Prodesse, Inc. | K153223, K132238 | |
ProFlu+ Assay | Hologic/Gen-Probe Prodesse, Inc. | K153219, K110968, K092500, K081030, K073029 | |
ProParaFlu + Assay | Prodesse, Inc. | K091053 | |
Quidel Molecular Influenza A + B Assay | Quidel Corporation | K131728, K113777, K112172 | |
Simplexa Flu A/B & RSV | Focus Diagnostics, Inc. | K102170 | |
Simplexa Flu A/B & RSV Direct | Focus Diagnostics, Inc. | K120413, K142365, K152408 | |
Simplexa Influenza A H1N1 (2009) | Focus Diagnostics, Inc . | K100148 | |
Solana Influenza A+B Assay | Quidel Corporation | K161814 | |
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) | Nanosphere, Inc. | K143653, K143653/S001 | |
Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) | Nanosphere, Inc. | K103209, K093337, K092957, K092566, K083088 | |
Xpert Xpress Flu | Cepheid | K162456, K162456/S001, K171552 | |
Xpert Flu + RSV Xpress | Cepheid | K151226, K162331, K162331/S001 | |
Xpert Flu Assay | Cepheid | K123191, K120911, K103766 | |
XPERT FLU/RSV XC ASSAY | Cepheid | K142045 | |
XPERT XPRESS FLU, XPERT NASOPHARYNGEAL SAMPLE COLLECTION KIT, XPERT NASAL SAMPLE COLLECTION KIT, GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI), GENEXPERT INFINITY-48S SYSTEM AND GENEXPERT INFINITY-80 SYSTEM | Cepheid | K181289 | |
xTAG Respiratory Viral Panel (RVP) | Luminex Molecular Diagnostics, Inc. | K112781, K112199, K091667, K081483, K063765 | |
xTAG Respiratory Viral Panel Fast (RVP FAST) | Luminex Molecular Diagnostics, Inc. | K103776 | |
ACCULA FLU A/FLU B TEST | MESA BIOTECH, INC. | K171641 | |
Alere I Influenza A & B 2, Alere I Instrument, Alere I Influenza A & B Control Swab Kit | Alere Scarborough, Inc. | K171792 | |
FilmArray Respiratory Panel 2.1(RP2.1) | BioFire Diagnostics, LLC | DEN200031 | |
FilmArray RP2/RP2plus Control Panel | Maine Molecular Quality Controls, Inc. | K173171 | |
FILMARRAY RESPIRATORY PANEL 2 PLUS (RP2PLUS) | BIOFIRE DIAGNOSTICS, LLC | DEN170017 | |
Panther Fusion AdV/HMPV/RV Assay | Hologic, Inc. | K172629 | |
Panther Fusion Paraflu Assay | Hologic, Inc. | K172282 | |
Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther | Hologic, Inc. | K171963 | |
Solana RSV+HMPV Assay | Quidel Corporation | K171974 | |
ID NOW Influenza A & B 2 | Alere Scarborough, Inc. | K190204 | |
ID NOW Influenza A & B 2 | Abbott Diagnostics Scarborough, Inc. | K191534 | |
Cobas Influenza A/B Nucleic Acid Test For Use On The Cobas Liat System | Roche Molecular Systems, Inc | K191729 | |
COBAS INFLUENZA A/B & RSV NUCLEIC ACID TEST FOR USE ON THE COBAS LIAT SYSTEM | Roche Molecular Systems, Inc | K210234 | |
FluChip-8G Influenza A+B Assay | InDevR, Inc | K182513 | |
Cdc Human Influenza Virus Real-Time Rt-Pcr Diagnostic Panel, Influenza A/B Typing Kit, Cdc Human Influenza Virus Real-Time Rt-Pcr Diagnostic Panel, Influenza A Subtyping Kit, Cdc Human Influenza Virus Real-Time Rt-Pcr, Influenza B Lineage Genotyping Kit, Cdc Human Influenza Virus Real-Time Rt-Pcr, | Centers For Disease Control And Prevention | K190302 | |
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 | |
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 |
ALERE I INFLUENZA A & B, ALERE I STREP A, ALERE I RSV, ALERE I INFLUENZA A & B 4 | Alere Scarborough, Inc. | K173932 | |
ALERE I STREP A 2, ALERE I INSTRUMENT, ALERE I STREP A 2 CONTROL SWAB KIT | Alere Scarborough, Inc. | K173653 | |
Leishmaniaspecies | SMART Leish | U.S. Army Medical Materiel Development Activity | K081868 |
Meningitis/Encephalitis | FilmArray Meningitis/Encephalitis(ME) Panel | BioFire Diagnostics LLC | DEN150013, DEN150013/S001, K160462 |
Mycobacterium tuberculosis | Xpert MTB/RIF Assay | Cepheid | K131706 |
BDProbetec ET Mycobacterium tuberculosis complex culture identification kit | Becton, Dickinson, & Co. | K000884 | |
Amplified Mycobacterium tuberculosis Direct Test | Gen-Probe, Inc. | P940034 | |
Amplicor Mycobacterium tuberculosis test | Roche Molecular Systems, Inc. | P940040 | |
SNAP M.tuberculosis complex | Syngene, Inc. | K900292 | |
Accuprobe Mycobacterium tuberculosis complex Test | Gen-Probe, Inc. | K896493 | |
Rapid Diagnostic System for Mycobacterium tuberculosis | Gen-Probe, Inc. | K871795 | |
Rapid Identification Test for Mycobacterium tuberculosis complex | Gen-Probe, Inc. | K862614 | |
Mycobacterium species | Accuprobe Mycobacterium avium complex culture | Gen-Probe, Inc. | K921435, K896494, K897078 |
Accuprobe Mycobacterium kansasii Identification Test | Gen-Probe, Inc. | K904463 | |
SNAP Mycobacterium avium complex | Syngene, Inc. | K900202 | |
Accuprobe Mycobacterium intracellulare Culture Identification Test | Gen-Probe, Inc. | K897077 | |
Accuprobe Mycobacterium gordonae culture identification Test | Gen-Probe, Inc. | K896492 | |
Rapid Diagnostic System for Mycobacterium gordonae | Gen-Probe, Inc. | K890089 | |
Rapid Diagnostic System for Mycobacteria | Gen-Probe, Inc. | K864597 | |
Rapid Identification Test for Mycobacterium avium | Gen-Probe, Inc. | K862613 | |
Gen-Probe Mycobacterium Rapid Confirmation System | Gen-Probe, Inc. | K860782 | |
Mycoplasma Genitalium | Aptima Mycoplasma Genitalium Assay | Hologic, Inc. | DEN180047 |
Mycoplasma genitalium (MG) and Trichomonas vaginalis (TV) | Cobas TV/MG For Use On Cobas 6800/8800 Systems, Cobas TV/MG Positive Control Kit, Cobas Buffer Negative Control Kit | Roche Molecular Systems, Inc. | K190433 |
Mycoplasma pneumoniae | illumigene Mycoplasma Direct DNA Amplification Assay | Meridian Bioscience, Inc. | K160829 |
illumigene Mycoplasma DNA Amplification Assay | Meridian Bioscience, Inc. | K152800, K123423 | |
Multiplex Panel | BD Max Vaginal Panel, BD MAX Instrument | GeneOhm Sciences Canada | DEN160001/ DEN160001/S001 |
BIOCODE GASTROINTESTINAL PATHOGEN PANEL (GPP) | APPLIED BIOCODE, INC. | K180041 | |
BioFire Blood Culture Identification 2 (BCID2) Panel | BioFire Diagnostics, LLC | K193519 | |
BioFire Joint Infection (JI) Panel | BioFire Diagnostics, LLC | DEN200066 | |
FilmArray BCID2 Control Panel M416 | Maine Molecular Quality Controls, Inc. | K200010 | |
Curetis Unyvero LRT Application | Curetis GmbH | DEN170047 | |
Unyvero LRT BAL Application | Curetis GmbH | K191967 | |
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel | GenMark Diagnostics, Inc | K213236 | |
ePlex instrument (multiplex) | GenMark Diagnostics, Inc | K163652, K163652/S001 | |
FilmArray BCID Panel | BioFire Defense, LLC | K143171, K160457 | |
FilmArray NGDS Warrior Panel | BioFire Defense, LLC | K170883, DEN160048 | |
FilmArray Warrior Control Panel | Maine Molecular Quality Controls, Inc. | K163522 | |
NEUMODX GBS ASSAY | NEUMODX MOLECULAR, INC. | K173725 | |
PANNAT STEC TEST | MICRONICS, INC | K173330 | |
ProGastro SSCS Assay | Gen-Probe Prodesse, Inc. | K123274 | |
Biocode Gastrointestinal Pathogen Panel (GPP) | Applied Biocode, Inc. | K190585 | |
EntericBio Dx Assay | Serosep, Ltd. | K182703 | |
xTAG Gastrointestinal Pathogen Panel (GPP) | Luminex Molecular Diagnostics, Inc. | K121894, K121454 | |
BD MAX Extended Enteric Bacterial Panel, BD MAX System | Becton Dickinson and Company | K170308 | |
BD MAX ENTERIC VIRAL PANEL, BD MAX INSTRUMENT | Becton Dickinson and Company | K181427 | |
FILMARRAY GASTROINTESTINAL (GI) PANEL | BIOFIRE DIAGNOSTICS | K140407, K160459, K160459/S001 | |
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | Luminex Molecular Diagnostics, Inc. | K191160 | |
xTAG Gastrointestinal Pathogen Panel (GPP) | Luminex Molecular Diagnostics, Inc. | K191161 | |
T2BACTERIA PANEL | T2 BIOSYSTEMS, INC. | K172708 | |
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | Luminex Molecular Diagnostics, Inc. | K191160 | |
xTAG Gastrointestinal Pathogen Panel (GPP) | Luminex Molecular Diagnostics, Inc. | K191161 | |
Great Basin Stool Bacterial Pathogens Panel | Great Basin Scientific, Inc. | K163571, K163571/S001 | |
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS | LUMINEX MOLECULAR DIAGNOSTICS INC. | K140377, K140647 | |
VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP) | NANOSPHERE, INC | K140083, K142033 | |
FILMARRAY PNEUMONIA PANEL | BioFire Diagnostics, LLC | K180966 | |
FILMARRAY PNEUMONIA PANEL PLUS | BioFire Diagnostics, LLC | K181324 | |
Multiplex Panel (Pneumonia) QC Material | FilmArray Pneumonia/Pneumoniaplus Control | Maine Molecular Quality Controls, Inc. (MMQCI) | K190222 |
Non-Variola Orthopoxvirus | NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET | Centers for Disease Control and Prevention | K181205 |
NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET | Centers for Disease Control and Prevention | DEN070001 | |
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 |
Visby Medical Sexual Health | Visby Medical | K200748 | |
Norovirus | RIDA GENE Nororvirus GI/GII | R-Biopharm AB | K171511 |
XPERT NOROVIRUS GENEXPERT Dx SYSTEMS (GX-I GX-11 GX-IV GX-XVI) GENEXPERT INFINITY-48 SYSTEM, GENEXPERT INFINITY-48S SYSTEM, GENEXPERT INFINITY-80 SYSTEM | CEPHEID | K142501 | |
Plasmodium | ID-FISH Plasmodium Genus Test Kit, ID-FISh P. falciparum and P. vivax Combo Test | ID-FISH Technology, Inc. | DEN160025, DEN160025/S001 |
Respiratory panel | QIAstat-Dx Respiratory Panel; QIAstat-Dx Analyzer | QIAGEN GmbH |
|
FilmArray Pneumonia Panel | BioFire Diagnostics, LLC | K212727 | |
Respiratory panel control material | Cepheid Xpert Respiratory Control Panel | Microbiologics, Inc. | K190086 |
BioFire RP2.1/RP2.1plus Control Panel M441 | Maine 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 |
Sepsis | SeptiCyte LAB | Immunexpress, Inc. | K163260 |
Staphylococcus | BD Max MRSA Assay | BD Diagnostics (GeneOhm Sciences Canada, Inc.) | K120138 |
Staphylococcus QuickFISH BC | AdvanDx, Inc. | K113371 | |
MRSA/SA ELITe MGB | EliTechGroup Epoch Biosciences. | K112937, K132468 | |
Verigene Staphylococcus Blood Culture (BC-S) Nucleic Acid Test | Nanosphere, Inc. | K112424 | |
NucliSENS EasyQ MRSA Assay | bioMerieux, Inc. | K102740 | |
Xpert MRSA/SA Blood Culture Assay | Cepheid | K101879, K082140 | |
Xpert MRSA/SA Nasal Complete Assay | Cepheid | K100822 | |
LightCycler MRSA Advanced Test | Roche Molecular Systems, Inc | K091409 | |
BD GeneOhm MRSA ACP Assay | BD Diagnostics (GeneOhm Sciences Canada, Inc.) | K093346 | |
S. aureus and/or other Staphylococcus species PNA FISH Culture | AdvanDx, Inc. | K092166 | |
Xpert MRSA/SA SSTI Assay | Cepheid | K080837 | |
BD GeneOhM StaphSR Assay | BD Diagnostics (GeneOhm Sciences Canada, Inc.) | K071026 | |
S. aureus PNA FISH | AdvanDx, Inc. | K091827, K060099 | |
Xpert MRSA | Cepheid | K070462 | |
IDI-MRSA Assay | Infectio Diagnostic, Inc. | K042357, K033415 | |
MECA XPRESSFISH | ADVANDX INC. | K140619 | |
COBAS MRSA/SA TEST | ROCHE MOLECULAR SYSTEMS INC. | K142721 | |
Xpert MRSA NxG | Cepheid | K162444 | |
Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System | Cepheid | K190771 | |
Staphylococcus / MRSA Control Material | Cepheid Xpert MRSA NxG Control Panel | Microbiologics, Inc. | K191172 |
Cepheid Xpert SA Nasal Complete Control Panel | Microbiologics, Inc. | K191168 | |
Streptococci | ARIES GBS Assay | Luminex Corporation | K162772 |
Xpert GBS LB Assay | Cepheid | K121539 | |
Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System | Cepheid | K203429 | |
illumigene Group A Streptococcus (GBS) DNA Amplification Assay | Meridian Bioscience, Inc. | K122019 | |
illumigene Group B Streptococcus (GBS) DNA Amplification Assay | Meridian Bioscience, Inc. | K121044 | |
BD Max GBS Assay | Becton, Dickinson, & Co. | K111860 | |
Cepheid Smart GBS Assay | Cepheid | K062948 | |
Xpert GBS | Cepheid | K060540 | |
IDI-Strep B Assay | Infectio Diagnostic, Inc. | K022504 | |
Gen-Probe Accuprobe Group B Streptococcus culture identification kit | Chugai Pharmaceuticals Co, Ltd. | K974572 | |
Accuprobe Streptococcus pneumoniae culture confirmation | Gen-Probe, Inc. | K902908 | |
ILLUMIGENE GROUP B STREPTOCOCCUS (GBS) DNA AMPLIFICATION ASSAY | MERIDIAN BIOSCIENCE, INC. | K112125 | |
AMPLIVUE GBS ASSAY | QUIDEL CORPORATION | K133503 | |
LYRA DIRECT STREP ASSAY | QUIDEL CORPORATION | K133883 (DEN140005) | |
AMPLIVUE GAS ASSAY | QUIDEL CORPORATION | K141173 | |
LIAT STREP A ASSAY | IQUUM INC | K141338 | |
revogene | GenePOC Inc. | K170558 | |
GenePOC GBS LB | GenePOC Inc. | K170557 | |
Solana Strep Complete Assay | Quidel Corporation | K162274 | |
ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit | Luminex Corporation | K172402 | |
Xpert Xpress Strep A | Cepheid | K172126; K173398 | |
GenePOC Strep A | GenePOC Inc. | K183366 | |
Streptococci / GBS Conrol Material | Cepheid Xpert GBS LB Control Panel | Microbiologics, Inc. | K182472 |
Shiga Toxin | Great Basin Shiga Toxin Direct Test | Great Basin Scientific, Inc. | K152955, K152955/S001, K152955/S002 |
Trichomonas vaginalis | Affirm VP Microbial Identification Test for Gardnerella vaginalis and Trichomonas vaginalis | Microprobe Corp. | K923133 |
Amplivue Trichomonas Assay | Quidel Corporation | K143329 | |
APTIMA Trichomonas vaginalis (ATV) Assay | Gen-Probe, Inc. | K102911 | |
APTIMA Trichomonas vaginalis Assay (PANTHER System) | Gen-Probe, Inc. | K122062 | |
BD ProbeTec Trichomonas vaginalis (TV) QX Amplified DNA Assay | Becton, Dickinson & Co. | K130268 | |
Solana Trichomonas Assay | Quidel Corporation | K161182, K161182/S001 | |
Xpert TV | Cepheid | K151565, K151565/S001, K161619 | |
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 MAX Vaginal Panel | GeneOhm Sciences Canada, Inc. (BD Diagnostics) | DEN160001 |
BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit | GeneOhm Sciences Canada, Inc. (BD Life Sciences) | K201017 | |
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | Cepheid | K212213 | |
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 |