Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                In Vitro Diagnostics

In Vitro Diagnostics

                        Companion Diagnostics
          Biotin Interference with Troponin Lab Tests - Assays Subject to Biotin Interference
          Direct-to-Consumer Tests
          Nucleic Acid Based Tests


                        Blood Glucose Monitoring Devices
          Drugs of Abuse Tests
          Home Use Tests
          Laboratory Developed Tests
          Precision Medicine
          Tests Used In Clinical Care
          Warfarin INR Test Meters Home
          Medical Devices
          Products and Medical Procedures
          In Vitro Diagnostics
          Nucleic Acid Based TestsIn Vitro Diagnostics Nucleic Acid Based Tests
  
  	
    Share
    Post
    Linkedin

    Email
    PrintThis 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
	List of Microbial TestsList of Human Genetic Tests

Disease/Use
			Trade Name
			Manufacturer
			SubmissionAcute Myeloid Leukemia
			Vysis D7S486/CEP 7 FISH Probe Kit
			Abbott Molecular Inc.
			K131508Vysis EGR1 FISH Probe Kit
			Abbott Molecular Inc.
			K123951,K091960LeukoStrat CDx FLT3 Mutation Assay
			INVIVOSCRIBE TECHNOLOGIES, INC
			P160040Abbott RealTime IDH2
			ABBOTT MOLECULAR, INC.
			P170005Abbott RealTime IDH1
			ABBOTT MOLECULAR, INC.
			P170041Acute Myeloid Leukemia or Myelodysplastic Syndrome
			VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION
			ABBOTT MOLECULAR, INC.
			DEN130010Aggressive Systemic Mastocytosi
			KIT D816V ASSAY
			ARUP LABARATORIES
			H140006Autosomal Recessive Carrier Screening
			23ANDME PERSONAL GENOME SERVICE
			23andMe
			DEN140044B-cell chronic lymphocytic leukemia
			VYSIS CLL FISH PROBE KIT
			ABBOTT MOLECULAR, INC
			K100015VYSIS CLL FISH PROBE KIT
			ABBOTT MOLECULAR, INC
			P150041CEP 12 SpectrumOrange Direct Labeled Chromosome Enumeration DNA Probe
			Vysis
			K962873Bladder Cancer
			Vysis UroVysion Bladder Cancer Recurrence Kit
			Vysis
			K033982, K013785, K011031Breast Cancer
			23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
			23andMe
			DEN170046Prosigna Breast Cancer Prognostic Gene Signature Assay
			Nanostring Technologies
			K130010MammaPrint
			Agendia BV
			K101454, K081092, K080252, K070675, K062694MammaPrint FFPE NGS Kit
			Agendia, Inc.
			K210973INFORM HER2 Dual ISH DNA Probe Cocktail
			Ventana Medical Systems, Inc.
			P100027*HER2* CISH pharmDxTM Kit
			Dako Denmark A/S
			P100024HER2 Dual ISH DNA Probe Cocktail
			Ventana Medical Systems, Inc.
			P190031GeneSearch Breast Lymph Node (BLN) Test Kit
			Veridex, LLC.
			P060017 S001-S004Dako TOP2A FISH PharmDx Kit
			Dako Denmark A/S
			P050045 S001-S004HER2 IQFISH PHARMDX
			DAKO DENMARK A/S
			P040005INSITE HER-2/NEU KIT
			BIOGENEX LABORATORIES, INC.
			P040030SPOT-LIGHT HER2 CISH KIT
			INVITROGEN CORPORATION
			P050040INFORM HER-2/NEU
			VENTANA MEDICAL SYSTEMS, INC.
			P940004DAKO HERCEPTEST
			DAKO A/S
			P980018PATH VYSION HER-2 DNA PROBE KIT
			ABBOTT MOLECULAR, INC.
			P980024DakoCytomation Her2 FISH pharmDxTM Kit
			DakoCytomation Denmark A/S
			P040005Therascreen PIK3CA RGQ PCR Kit
			QIAGEN GMBH
			P190001Therascreen PIK3CA RGQ PCR Kit
			QIAGEN GMBH
			P190004Cell-free DNA blood collection device
			Cell-Free DNA BCT
			Streck, Inc.
			DEN200001Chromosome abnormalities
			Affymetrix CytoScan Dx Assay
			Affymetrix, Inc.
			K130313AneuVysion
			Vysis
			K010288, K972200CYTOSCAN(R) DX
			Affymetrix, Inc.
			DEN130018GenetiSure Dx Postnatal Assay
			Agilent Technologies, Inc.
			K163367CEP 8 Spectrumorange DNA Probe Kit
			Vysis
			K953591CEP X SpectrumOrange/ Y SpectrumGreen DNA Probe Kit
			Vysis
			K954214Chronic Myeloid Leukemia
			Quantidex qPCR BCR-ABL IS Kit
			ASURAGEN, INC.
			DEN160003Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s And GeneXpert Infinity-80 Systems
			Cepheid
			K190076QXDx BCR-ABL %IS Kit For Use On The QXDx AutoDG DdPCR System
			Bio-Rad Laboratories, Inc.
			K181661MRDx BCR-ABL Test, MRDx BCR-ABL Test Software
			MolecularMD Corporation
			K173492Coagulation Factors
			Invader Factor V
			Hologic, Inc.
			K100980Invader Factor II
			Hologic, Inc.
			K100943Illumina VeraCode Genotyping Test for Factor V and Factor II
			Illumina, Inc.
			K093129eSensor Thrombophilia Risk Test, eSensor FII-FV Genotyping Test, eSensor Fll Genotyping Test, eSensor FV Genotyping Test, eSensor MTHFR Genotyping Test
			Osmetech Molecular Diagnostics
			K093974Xpert HemosIL FII & FV
			Cepheid
			K082118Verigene F5 Nucleic Acid Test
			Verigene F2 Nucleic Acid Test
			Verigene MTHFR Nucleic Acid Test
			Nanosphere, Inc.
			K070597INFINITI System
			Autogenomics, Inc.
			K060564Factor II (Prothrombin) G20210A Kit
			Roche Diagnostics Corporation
			K033612Factor V leiden Kit
			Roche Diagnostics Corporation
			K033607Invader MTHFR 677
			Hologic, Inc.
			K100987Invader MTHFR 1298
			Hologic, Inc.
			K100496COAGULATION, 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
			DEN160026Health Risk Assessment System
			AncestryDNA Factor V Leiden Genetic Health Risk Test
			Ancestry Genomics, Inc.
			K192944Colorectal Cancer
			*Cologuard*
			Exact Sciences Corporation
			P130017Therascreen KRAS RGQ PCR Kit
			QIAGEN MANCHESTER LTD
			P110027/P110030Therascreen BRAF V600E RGQ PCR Kit
			QIAGEN MANCHESTER LTD
			P190026Epi ProColon®
			Epigenomics AG
			P130001Cobas KRAS MUTATION TEST
			Roche Molecular Systems, Inc.
			P140023Praxis Extended RAS Panel
			Illumina, Inc.
			P160038VENTANA 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
			DEN170030Colorectal Cancer Predisposition
			MUTYH-Associated Polyposis (MAP)
			23andMe
			K182784Cystic Fibrosis
			Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay
			Illumina, Inc
			K132750Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay
			Illumina, Inc
			K124006xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR
			Luminex Molecular Diagnostics, Inc.
			K163336xTAG Cystic Fibrosis 39 Kit v2
			Luminex Molecular Diagnostics, Inc.
			K163347eSensor CF Genotyping Test
			Osmetech Molecular Diagnostics
			K090901xTAG Cystic Fibrosis 60 Kit v2
			Luminex Molecular Diagnostics Inc.
			K083845xTAG Cystic Fibrosis 39 Kit v2
			Luminex Molecular Diagnostics Inc.
			K083846Verigene CFTR and Verigene CFTR PolyT Nucleic Acid Tests
			Nanosphere, Inc
			K083294InPlex CF Molecular Test
			Third Wave Technology, Inc.
			K063787Cystic Fibrosis Genotyping Assay
			Celera Diagnostics
			K062028Tag-It Cystic Fibrosis Kit
			Tm Bioscience Corporation
			K060627, K043011eSensor Cystic Fibrosis Carrier Detection System
			Clinical Micro Sensors, Inc.
			K060543, K051435Drug Metabolizing enzymes
			xTAG CYP2D6 Kit v3
			Luminex Molecular Diagnostics, Inc.
			K130189, K093420xTAG CYP2D6 Kit v3
			Luminex Molecular Diagnostics, Inc.
			K130189, K131565Spartan RX CYP2C19 Test System
			Akonni Biosystems Inc.
			K183530TruDiagnosis System
			Akonni Biosystems Inc
			K183530Verigene CYP2C 19 Nucleic Acid Test
			Nanosphere, Inc.
			K120466INFINITI CYP2C19 Assay
			AutoGenomics, Inc.
			K101683Invader UGT1A1 Molecular Assay
			Third Wave Technologies Inc.
			K051824Roche AmpliChip CYP450 microarray
			Roche Molecular Systems, Inc.
			K043576, K042259eSensor Warfarin Sensitivity Saliva Test
			GenMark Diagnostics
			K110786eQ-PCR LC Warfarin Genotyping kit
			TrimGen Corporation
			K073071eSensor Warfarin Sensitivity Test and XT-8 Instrument
			Osmetech Molecular Diagnostics
			K073720Gentris Rapid Genotyping Assay - CYP2C9 & VKORCI
			ParagonDx, LLC
			K071867INFINITI 2C9 & VKORC1 Assay for Warfarin
			AutoGenomics, Inc.
			K073014Verigene Warfarin Metabolism Nucleic Acid Test and Verigene System
			Nanosphere, Inc.
			K070804Endometrial Cancer
			VENTANA MMR RxDx Panel
			Ventana Medical Systems, Inc.
			P200019Follicular Lymphoma (Somatic Gene Mutation Detection System)
			Cobas EZH2 Mutation Test
			Roche Molecular System, Inc.
			P200014Fragile X
			AmplideX Fragile X Dx & Carrier Screen Kit
			Asuragen, Inc
			DEN190023Heart Transplant
			AlloMap Molecular Expression Testing
			xDx
			K073482Hematologic 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
			DEN170070Hematologic Malignancies
			Adaptive Biotechnologies ClonoSEQ Assay
			Adaptive Biotechnologies Corporation
			K200009HEREDITARY THROMBOPHILIA
			IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST
			SEQUENOM, INC./AGENA Bioscience
			K132978Lung and Colon Cancer Assay
			ONCO/Reveal Dx Lung & Colon Cancer Assay
			Pillar Biosciences, Inc.
			P200011Lynch Syndrome Test System
			OncoMate MSI Dx Analysis System
			Promega Corporation
			K200129Melanoma
			Roche cobas DNA Sample Preparation Kit, COBAS 4800 BRAF V600 MUTATION TEST
			Roche Molecular Systems, Inc.
			P110020THXID-BRAF KIT
			BioMerieux, Inc.
			P120014Multiple Myeloma / Acute Lymphoblastic Leukemia (MRD)
			ADAPTIVE BIOTECHNOLOGIES CLONOSEQ ASSAY
			ADAPTIVE BIOTECHNOLOGIES CORPORATION
			DEN170080Myelodysplastic syndrome / myeloproliferative disease
			Fluorescence in situ hybridization, platelet-derived growth factor receptor, beta polypeptide (pdgfrb), rearrangement
			ARUP LABARATORIES
			H140005Myeloproliferative disease / Polycythemia Vera
			Ipsogen JAK2 RGQ PCR Kit
			QIAGEN INC
			DEN160028Myeloproliferative disease / Polycythemia Vera
			Ipsogen JAK2 RGQ PCR Kit
			QIAGEN INC
			K172287Non-microbial analyte(s) in patients with suspected sepsis
			xSeptiCyte RAPID
			Immunexpress, Inc
			K203748Non-Small Cell Lung Cancer
			VYSIS ALK BREAK APART FISH PROBE KIT
			ABBOTT MOLECULAR, INC.
			P110012Cobas EGFR MUTATION TEST v2
			Roche Molecular Systems, Inc.
			P120019THERASCREEN EGFR RGQ PCR KIT
			QIAGEN MANCHESTER LTD
			P120022Cobas EGFR MUTATION TEST v2
			Roche Molecular Systems, Inc.
			P150044Cobas EGFR MUTATION TEST v2
			Roche Molecular Systems, Inc.
			P150047Oncomine Dx Target Test
			LIFE TECHNOLOGIES CORPORATION
			P160045Ovarian Cancer
			BRACAnalysis CDx
			Myriad Genetic Laboratories, Inc.
			P140020FoundationFocus CDxBRCA
			FOUNDATION MEDICINE, INC
			P160018Pharmacogenetic Reports
			23ANDME PERSONAL GENOME SERVICE (PGS) PHARMACOGENETIC REPORTS
			23andMe
			DEN180028, K193492, K221885Platforms, Imaging Systems, and Reagents
			ILLUMINA MISEQDX PLATFORM
			Illumina, Inc
			DEN130011MISEQDX UNIVERSAL KIT 1.0
			Illumina, Inc.
			DEN130042DUET SYSTEM
			BIOVIEW LTD.
			K130775Prostate Cancer
			NADiA ProsVue
			Iris Molecular Diagnostics
			K101185PROGENSA PCA3 Assay
			Gen-Probe, Inc.
			P100033Prostate Cancer Predisposition (HOXB13-Related)
			23andMe PGS Genetic Risk Report For Hereditary Prostate Cancer (HOXB13-Related)
			23andMe, Inc.
			K211499Setmelanotide eligibility gene variant detection system
			POMC/PCSK1/LEPR CDx Panel
			PreventionGenetics, LLC
			DEN200059Severe Combined Immunodeficiency Disorder (SCID)
			PerkinElmer Enlite TREC Test System
			Wallac OY
			DEN140010Eonis SCID-SMA Kit
			Perkin-Elmer Inc
			K203035Saliva DNA Specimen Collection Device
			AncestryDNA Saliva Collection Kit
			Ancestry Genomics, Inc.
			K192947Spinal Muscular Atrophy Newborn Screening Test System
			Eonis SCID-SMA Kit
			Perkin-Elmer Inc
			DEN200044Tissue of Origin
			Pathwork Tissue of Origin Test Kit – FFPE
			Pathwork Diagnostics Inc.
			K120489, K092967Pathwork Tissue of Origin Test
			Pathwork Diagnostics Inc.
			K080896Tissue of Origin Test Kit - FFPE
			Cancer Genetics, Inc.
			K173839Follicular Lymphoma

			(Somatic Gene Mutation Detection System)
			Cobas® EZH2 Mutation Test
			Roche Molecular System, Inc.
			P200014Tumor Profiling
			MSK-IMPACT (Integrated Mutation Profiling Of Actionable Cancer Targets):A Hybridization-Capture Based Next Generation Sequencing Assay
			Memorial Sloan-Kettering Cancer Center
			DEN170058FoundationOne CDx
			Foundation Medicine, Inc.
			P170019xT CDx
			Tempus Labs, Inc.
			P210011Tumor Profiling
			FoundationOne Liquid CDx (F1 Liquid CDx)
			Foundation Medicine, Inc.
			P200006Tumor Profiling
			Myriad myChoice CDx
			Myriad Genetic Laboratories, Inc.
			P190014Tumor Profiling
			NYU Langone Genome PACT
			NYU Langone Medical Center
			K202304Tumor Profiling
			Omics Core
			NantHealth, Inc..
			K190661Tumor Profiling
			PGDx elio tissue complete
			Personal Genome Diagnostics
			K192063Tumor Profiling; NSCLC
			Guardant360® CDx
			Guardant Health, Inc.
			P200010Tumor Profiling, Liquid Biopsy
			FoundationOne® Liquid CDx
			Foundation Medicine, Inc.
			P190032Urothelial Cancer
			Therascreen FGFR RGQ RT-PCR Kit
			QIAGEN GmbH
			P180043Whole 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
			K121942Lyra Adenovirus Assay
			Quidel Corportation
			K141931ProAdeno+ Assay
			Gen-Probe Prodesse, Inc.
			K102952Prodesse ProAdeno + Assay
			Gen-Probe Prodesse, Inc.
			K132159Antimicrobial resistance
			GenePOC Carba
			GenePOC Inc.
			K190275Antimicrobial resistance
			Accelerate Pheno System, Accelerate PhenoTest BC Kit
			Accelerate Diagnostics, Inc.
			K192665Acuitas 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
			K192871Bacterial vaginosis (BV) markers
			Aptima BV Assay
			Hologic, Inc.
			K190452*Bordetella*
			ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit
			Luminex Corporation
			K163626, K163626/S001AMPLIVUE BORDETELLA ASSAY
			QUIDEL CORPORATION
			K143206Great Basin Bordetella Direct Test
			Great Basin Scientific, Inc.
			K170284ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT ILLUMIPRO-10 AUTOMATED ISOTHERMA
			MERIDIAN BIOSCIENCE, INC.
			K133673, K152285SIMPLEXA BORDETELLA DIRECT, SIMPLEXA BORDETELLA POSITIVE CONTROL PACK
			DIASORIN MOLECULAR LLC
			K173498SIMPLEXA 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, K931374Yeast Traffic Light PNA FISH
			AdvanDx, Inc.
			K093024, K080719C. albicans / C. glabrata PNA FISH
			AdvanDx, Inc.
			K092784C. albicans PNA FISH
			AdvanDx, Inc.
			K092655, K062461C. Albicans screen
			Carr-Scarborough Microbiologicals, Inc.
			K891476T2Candida 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)
			K190472Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis
			BD CTGCTV2
			Becton Dickinson and Company
			K210585Visby Medical Sexual Health Test
			Visby Medical
			K220407Chlamydia 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
			K171441Solana C. difficile Assay
			Quidel Corporation
			K170491ICEPlex C. difficile Kit
			PrimeraDx
			K132726IMDx C. difficile for Abbott m2000
			Intelligent Medical Devices, Inc.
			K132235BD Diagnostics BD MAX Cdiff Assay
			GeneOhm Sciences Canada Inc.
			K130470Quidel Molecular Direct C. difficile Assay
			Quidel Corporation
			K123998Verigene C. Difficile Nucleic acid Test
			Nanosphere, Inc.
			K123197Portrait Toxigenic C. difficile Assay
			Great Basin Scientific, Inc.
			K113358Simplexa C. difficile Universal Direct Assay
			Focus Diagnostics, Inc.
			K113433, K163085, K163085/S001Xpert C. difficile/Epi
			Cepheid
			K110203Illumigene C. difficile DNA Amplification Assay
			Meridian Bioscience, Inc.
			K110012Illumigene C. difficile Assay
			Meridian Bioscience, Inc.
			K100818, K110012Xpert C. difficile
			Cepheid
			K091109ProGastro Cd Assay
			Prodesse Inc.
			K090239BD GeneOhm C. diff Assay
			BD Diagnostics/ GeneOhm Sciences, Inc.
			K081920ARTUS C. DIFFICILE QS-RGQ MDX KIT
			QIAGEN, GMBH
			K133936AMPLIVUE C. DIFFICILE ASSAY
			QUIDEL CORPORATION
			K123355GenePOC CDiff
			GenePOC Inc
			K172569Cobas 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.
			K190463Clostridium difficile Toxin Gene
			Cobas Cdiff nucleic acid test for use on the cobas Liat System
			Roche Molecular Systems, Inc
			K210385Cobas 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, K080739Accuprobe Neisseria gonorrhoeae Culture Confirmation Test
			Gen-Probe, Inc.
			K895583Amplicor Chlamydia trachomatis Test
			Roche Molecular Systems, Inc.
			K922906AMPLICOR CT/NG Test for Chlamydia trachomatis
			Roche Molecular Systems, Inc.
			K973707AMPLICOR CT/NG test for Chlamydia trachomatis
			Roche Diagnostics Corp.
			K070174AMPLICOR CT/NG test for Neisseria gonorrhoeae
			Roche Diagnostics Corp.
			K070172APTIMA Combo 2 Assay
			Gen-Probe, Inc.
			K111409APTIMA Combo 2 Assay (Panther System)
			Hologic/Gen-Probe, Inc.
			K132251K190515K220321Aptima Combo 2® Assay (Panther® System)

			Aptima Combo 2® Assay (Tigris® DTS® System)
			Hologic, Inc.
			K200866K220321BD MAX CT/GC/TV, BD MAX Instrument
			Becton, Dickinson, & Co.
			K151589, K151589/S001, K151589/S002BD ProbeTec Chlamydia trachomatis (CT) Qx Amplified DNA Assay
			Becton, Dickinson, & Co.
			K091724, K090824, K081824BD Probetec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay
			Becton, Dickinson, & Co.
			K091730, K090971, K090827, K081825BD ProbeTec Chlamydia trachomatis (CT) Qx Amplified DNA Assay on the BD Viper LT System
			Becton, Dickinson, & Co.
			K140446BD Probetec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay on the BD Viper LT System
			Becton, Dickinson, & Co.
			K140048BDProbeTec ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays
			Becton Dickinson Microbiology Systems
			K984631BDProbeTec ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays
			Becton, Dickinson, & Co.
			K012351binx health io CT/NG Assay
			binx health, Inc.
			K191352binx io CT/NG Assay and binx io CT/NG System
			binx health Inc
			K200533COBAS 4800 CT/NG Test
			Roche Molecular Systems, Inc.
			K110923COBAS AMPLICOR CT/NG test for Chlamydia trachomatis
			Roche Molecular Systems, Inc.
			K973718COBAS AMPLICOR CT/NG test for Chlamydia trachomatis
			Roche Diagnostics Corp.
			K053287COBAS AMPLICOR CT/NG test for Neisseria gonorrhoeae
			Roche Molecular Systems, Inc.
			K974342COBAS AMPLICOR CT/NG test for Neisseria gonorrhoeae
			Roche Diagnostics Corp.
			K053289COBAS CT/NG FOR USE ON COBAS 6800/8800 SYSTEMS
			Roche Molecular Systems, Inc.
			K173887cobas CT/NG v2.0 Test
			Roche Molecular Systems, Inc.
			K132270, K140887, K163184cobas CTNG for use on cobas 6800/8800 systems
			Roche Molecular Systems, Inc.
			K202408GEN-PROBE AMPLIFIED Chlamydia trachomatis Assay Kit
			Gen-Probe, Inc.
			K962217GEN-PROBE APTIMA Assay for Neisseria gonorrhoeae
			Gen-Probe, Inc.
			K063664, K062440, K043144GEN-PROBE APTIMA Assay for Chlamydia trachomatis
			Gen-Probe, Inc.
			K063451, K053446, K043072GEN-PROBE APTIMA Combo 2 Assay
			Gen-Probe, Inc.
			K043224, K032554, K003395GEN-PROBE PACE 2C System for Chlamydia trachomatis and Neisseria gonorrhoeae
			Gen-Probe, Inc.
			K940979GONOSPOT DNA Probe Culture Confirmation Test
			Ortho Diagnostic Systems, Inc.
			K872628GONOSTAT Gonococcal Detection Kit
			Sierra Diagnostics, Inc.
			K991268Hybrid Capture II CT/GC Test
			Digene Corp.
			K981567, K010891Hybrid Capture II CT-ID Test
			Digene Corp.
			K990023, K010892Hybrid Capture II GC-ID Test
			Digene Corp.
			K981485, K010893LCx Chlamydia trachomatis Assay
			Abbott Laboratories
			K934622LCx Neisseria gonorrhoeae Assay
			Abbott Laboratories
			K935833PACE 2 Chlamydia trachomatis probe confirmation assay
			Gen-Probe, Inc.
			K920302PACE 2 Neisseria gonorrhoeae probe confirmation assay
			Gen-Probe, Inc.
			K920301PACE 2 System for Chlamydia trachomatis
			Gen-Probe, Inc.
			K920378GEN-PROBE PACE System for Chlamydia trachomatis
			Gen-Probe, Inc.
			K874878GEN-PROBE System for Neisseria gonorrhoeae
			Gen-Probe, Inc.
			K874620PACE System for Neisseria gonorrhoeae
			Gen-Probe, Inc.
			K881277Rapid Diagnostic System for Chlamydia trachomatis
			Gen-Probe, Inc.
			K871878Roche AMPLICOR CT/NG test for Neisseria gonorrhoeae
			Roche Molecular Systems, Inc.
			K974503Roche COBAS AMPLICOR Chlamydia trachomatis test
			Roche Molecular Systems, Inc.
			K964507TIGRIS DTS Automated Analyzer APTIMA Assay for Chlamydia trachomatis
			Gen-Probe, Inc.
			K061413TIGRIS DTS GEN-PROBE APTIMA Assay for Neisseria gonorrhoeae
			Gen-Probe, Inc.
			K061509TIGRIS DTS GEN-PROBE APTIMA COMBO 2 Assay
			Gen-Probe, Inc.
			K060652Xpert CT/NG
			Cepheid
			K121710Xpert CT/NG
			Cepheid
			K190441*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
			P160044Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit
			Meridian Bioscience, Inc.
			DEN180040ARTUS CMV RGQ MDX Kit
			QIAGEN
			P130027Alinity M CMV
			Abbott Molecular, Inc.
			P210022Aptima CMV Quant Assay
			Hologic, Inc.
			P210029COBAS AmpliPrep/COBAS TaqMan CMV Test
			Roche Molecular Systems
			P110037COBAS CMV Test
			Roche Molecular Systems
			P160041NucliSens CMV pp67
			Organon Teknika Corporation
			K983762Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack
			DiaSorin Molecular LLC
			K202755*Dengue virus*
			CDC DENV-1-4 Real-Time RT-PCR Assay
			Centers for Disease Control and Prevention
			K113336EBV Nuclear Antigen-1 DNA / Head and neck cancer associated viruses
			NP Screen
			Advance Sentry Corporation
			DEN190031EBV / BKV
			cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
			Roche Molecular Systems, Inc
			K202215BKV / Quantitative viral nucleic acid test for transplant patient management
			cobas BKV
			Roche Molecular Systems, Inc.
			K203220EBV / Quantitative viral nucleic acid test for transplant patient management
			cobas EBV
			Roche Molecular Systems, Inc.
			DEN200015ALINITY 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.
			K123753BD GeneOhm VanR Assay
			BD Diagnostics (GeneOhm Sciences, Inc.)
			K102416Xpert vanA Assay
			Cepheid
			K092953E. faecalis/OE PNA
			AdvanDx, Inc.
			K083074GBS PNA FISH
			AdvanDx, Inc.
			K082612E. 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.
			K101558E. coli/P. aeruginosa PNA FISH
			AdvanDx, Inc.
			K092236, K081309EK/P aeruginosa PNA FISH
			AdvanDx, Inc.
			K092393, K081433E. 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/S001Great Basin Staph ID/R Blood Culture Panel
			Great Basin Scientific, Inc.
			K152470, K152470/S001hemoFISH Masterpanel
			Miacom Diagnostics GMBH
			K150031, K150031/S001IC-GPC Assay for use on the IC-System (positive blood cultures)
			iCubate, Inc.
			K163390, K163390/S001Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP)
			Nanosphere, Inc.
			K122514, K113450Xpert Carba-R (GNR)
			Cepheid
			K152614, K152614/S001, K160901 (Rectal Swabs)EPLEX BLOOD CULTURE IDENTIFICATION PANEL - GRAM POSITIVE (BCID-GP) PANEL
			GENMARK DIAGNOSTICS, INCORPORATED
			K181663EPlex Blood Culture Identification Gram Negative (BCID-GN) Panel
			GenMark Diagnostics, Incorporated
			K182619IC-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/S001ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit
			Luminex Corporation
			K151906ARIES System
			Luminex Corporation
			K160517, K160517/S001ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD)
			Luminex Corporation
			K161495IsoAmp HSV Assay
			BioHelix Corporation
			K111951MultiCode-RTx Herpes Simplex Virus 1 & 2 Kit
			EraGen Biosciences, Inc.
			K111527, K100336BD ProbeTec Herpes Simplex Viruses (HSV I & 2) QX Amplified DNA Assays
			BD Diagnostic Systems
			K103798SIMPLEXA HSV 1&2 DIRECT
			FOCUS DIAGNOSTICS
			K133621 (DEN130049)AMIPLIVUE HSV 1&2 ASSAY
			QUIDEL CORPORATION
			K140029illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit
			Meridian Bioscience, Inc.
			K151046IMDX HSV-1/2 FOR ABBOTT M2000
			INTELLIGENT MEDICAL, INC.
			K140198SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK
			FOCUS DIAGNOSTICS
			K141458, K151565, K151565/S001SIMPLEXA HSV 1 & 2 DIRECT, SIMPLEXA HSV 1 & 2 Positive Control Pack
			DIASORIN MOLECULAR LLC
			K173798Solana HSV 1+2/VZV Assay
			Quidel Corporation
			K162451ARTUS HSV-1/2 QS-RGQ MDx KIT
			QIAGEN
			K142738SEEGENE ANYPLEX II HSV-1/2 ASSAY
			SEEGENE
			K142156QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY
			DIAGNOSTIC HYBRIDS INC.
			K133448 (DEN140004)SENTOSA SA201 HSV 1/2 QUALITATIVE PCR TEST
			VELA DIAGNOSTICS USA INC.
			K172509HSV 1 & 2 ELITE MGB KIT; ELITE INGENIUS
			ELITECHGROUP
			K180559*Hepatitis virus*
			Abbott RealTime HCV Genotype II
			Abbott Molecular, Inc.
			P120012 S001-S0016Abbott Realtime HCV Assay
			Abbott Molecular, Inc.
			P100017 S001-S006, S007-S012, S014-S019Alinity m HCV
			Abbott Molecular, Inc.
			P190025Abbott Realtime HBV Assay
			Abbott Molecular, Inc.
			P080026 S001-S004, S005-S014, S016-S020Aptima HCV Quant Dx Assay
			Hologic, Inc.
			P160023COBAS HBV Test
			Roche Molecular Systems
			P150014 S001-S008Alinity m HBV
			Abbott Molecular, Inc.
			P200013COBAS HCV Test
			Roche Molecular Systems
			P150015 S001-S007P160016K221007COBAS AmpliPrep/COBAS TaqMan HCV test
			Roche Molecular Systems
			P060030 S001-S032, S033-S047, S048-S058COBAS Taqman HBV Test
			Roche Molecular Systems, Inc.
			P050028 S001-S027, S028-S047, S048, S050-S057Versant HCV 3.0 Assay (bDNA)
			Siemens Healthcare Diagnostics
			P020022Versant HCV RNA Qualitative Assay
			Gen-Probe, Inc.
			P020011 S001-S007, S008, S009COBAS AMPLICOR Hepatitis C Virus (HCV) Test
			Roche Molecular Systems, Inc.
			P000012 S001-S043, S044-S053, S054-S056AMPLICOR HCV Test, v2.0
			Roche Molecular Systems, Inc.
			P000010 S001-S024APTIMA HBV QUANT ASSAY
			HOLOGIC, INC
			P170025*Human Metapneumovirus*
			Pro hMPV+ Assay
			Gen-Probe Prodesse, Inc.
			K132200, K082688, K123838Quidel Molecular hMPV Assay
			Quidel Corporation
			K112490Quidel Molecular RSV + hMPV Assay
			Quidel Corporation
			K131813, K122189*Human Papillomvirus*
			APTIMA HPV 16 18/45 Genotype Assay
			Gen-Probe, Inc.
			P120007 S001-S010APTIMA HPV Assay
			Gen-Probe, Inc.
			P100042 S001-S012BD ONCLARITY HPV ASSAY
			BECTON, DICKINSON AND COMPANY
			P160037cobas HPV for use on the cobas 6800/8800 Systems
			Roche Molecular Systems, Inc
			P190028Cervista HPV 16/18
			Hologic, Inc.
			P080015;S001-S012Cervista HPV HR and Genfind DNA Extraction Kit
			Hologic, Inc.
			P080014 S001-S018COBAS HPV Test
			Roche Molecular Systems, Inc.
			P100020 S001-S024Digene Hybrid Capture 2 High-Risk HPV DNA Test
			Digene Corporation
			P890064 S001-S034*Influenza and Respiratory Viruses*
			PLEX-ID Flu assay
			Abbott Laboratories
			K121003Alere i Influenza A & B
			ALERE SCARBOROUGH, INC D/B/A BINAX, INC
			K141520, K151464, K151690, K163266Alere i RSV
			Alere Scarborough, Inc.
			K161375ARIES Flu A/B & RSV Assay
			Luminex Corporation
			K161220artus Infl A/B RG RT-PCR Kit
			Qiagen GmbH
			K113323CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel
			Centers for Disease Control and Prevention
			K080570CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel
			Centers for Disease Control and Prevention
			K133869, K132508, K130551, K123905, K111507, K161556CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit
			Centers for Disease Control and Prevention
			K161556CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit
			Centers for Disease Control and Prevention
			K172091CDC 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
			K200370CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL INFLUENZA A/H5 SUBTYPING
			CENTERS FOR DISEASE CONTROL AND PREVENTION
			K141859, K153148CDC Influenza 2009 A (H1N1) pdm Real-Time RT-PCR Panel
			Centers for Disease Control and Prevention
			K101564CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel Influenza B Lineage Genotyping Kit
			Centers for Disease Control and Prevention
			K181736XPERT XPRESS FLU/RSV, XPERT Nasopharyngral Sample Collection Kit, XPERT Nasal Sample Collection Kit, GENEXPERT XPRESS II, GENEXPERT XPRESS IV
			Cepheid
			K180218ACCULA RSV TEST
			MESA BIOTECH, INC.
			K181443BioCode Respiratory Pathogen Panel (RPP)
			Applied BioCode, Inc
			K192485cobas Liat Influenza A/B & RSV
			Iquum, Inc.
			K153544, K153544/S001eNAT molecular collection and preservation medium
			Copan Italia S.p.A.
			K201849DNA/RNA Shield Collection Tube
			Zymo Research
			K202641ePlex Respiratory Pathogen Panel
			GenMark Diagnostics, Inc
			K163636, K163636/S001eSensor Respiratory Viral Panel (RVP)
			Clinical Micro Sensors, Inc.
			K113731FilmArray Respiratory Panel (RP)
			Idaho Technology, Inc.
			K120267, K110764, K103175FilmArray Respiratory Panel (RP)
			BioFire Diagnostics, LLC
			K123620, K143080, K160068FilmArray Respiratory Panel 2 (RP2)
			BioFire Diagnostics, LLC
			K170604FilmArray Respiratory Panel EZ (RP EZ)
			BioFire Diagnostics, LLC
			K152579, K152579/S001, K152579/S002FilmArray RP EZ Control Panel M265
			Maine Molecular Quality Controls, Inc.
			K161573Idylla Respiratory (IFV-RSV) Panel
			Janssen Pharmaceutica NV
			K163628, K163629, K163630IMDx Flu A/B and RSV for Abbott m2000
			Intelligent Medical Devices, Inc.
			K131584INFLUENZA A SUBTYPING KIT CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
			CENTERS FOR DISEASE CONTROL AND PREVENTION
			K140851Influenza A/H5 (Asian lineage) Virus Real-time RT-PCR Primer and Probe Set
			Centers for Disease Control and Prevention
			K060159INFLUENZA B LINEAGE GENOTYPING KIT CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
			CENTERS FOR DISEASE CONTROL AND PREVENTION
			K140857JBAIDS Influenza A Subtyping Kit
			U.S. Army Medical Materiel Development Activity
			K111778JBAIDS Influenza A&B Detection Kit
			U.S. Army Medical Materiel Development Activity
			K111775, K152523JBAIDS Influenza A/H5 (Asian lineage) Detection Kit
			U.S. Army Medical Materiel Development Activity
			K100287Liat Influenza A/B Assay
			IQuum, Inc.
			K111387Lyra Influenza A+B Assay
			Quidel Corporation
			K230236LYRA PARAINFLUENZA VIRUS ASSAY
			QUIDEL CORPORATION
			K141927NxTAG Respiratory Pathogen Panel
			Luminex Molecular Diagnostics, Inc.
			K152386, K152386/S001NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
			Luminex Molecular Diagnostics, Inc.
			K193167Prodesse ProFAST Assay
			Gen-Probe Prodesse, Inc.
			K132237Prodesse ProFlu + Assay
			Gen-Probe Prodesse, Inc.
			K132129Prodesse ProParaflu Assay
			Gen-Probe Prodesse, Inc.
			K132238, K091053Prodesse ProParaflu Assay
			Hologic/Gen-Probe Prodesse, Inc.
			K153223, K132238ProFlu+ Assay
			Hologic/Gen-Probe Prodesse, Inc.
			K153219, K110968, K092500, K081030, K073029ProParaFlu + Assay
			Prodesse, Inc.
			K091053Quidel Molecular Influenza A + B Assay
			Quidel Corporation
			K131728, K113777, K112172Simplexa Flu A/B & RSV
			Focus Diagnostics, Inc.
			K102170Simplexa Flu A/B & RSV Direct
			Focus Diagnostics, Inc.
			K120413, K142365, K152408Simplexa Influenza A H1N1 (2009)
			Focus Diagnostics, Inc .
			K100148Solana Influenza A+B Assay
			Quidel Corporation
			K161814Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)
			Nanosphere, Inc.
			K143653, K143653/S001Verigene Respiratory Virus Plus Nucleic Acid Test (RV+)
			Nanosphere, Inc.
			K103209, K093337, K092957, K092566, K083088Xpert Xpress Flu
			Cepheid
			K162456, K162456/S001, K171552Xpert Flu + RSV Xpress
			Cepheid
			K151226, K162331, K162331/S001Xpert Flu Assay
			Cepheid
			K123191, K120911, K103766XPERT FLU/RSV XC ASSAY
			Cepheid
			K142045XPERT 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
			K181289xTAG Respiratory Viral Panel (RVP)
			Luminex Molecular Diagnostics, Inc.
			K112781, K112199, K091667, K081483, K063765xTAG Respiratory Viral Panel Fast (RVP FAST)
			Luminex Molecular Diagnostics, Inc.
			K103776ACCULA FLU A/FLU B TEST
			MESA BIOTECH, INC.
			K171641Alere I Influenza A & B 2, Alere I Instrument, Alere I Influenza A & B Control Swab Kit
			Alere Scarborough, Inc.
			K171792FilmArray Respiratory Panel 2.1(RP2.1)
			BioFire Diagnostics, LLC
			DEN200031FilmArray RP2/RP2plus Control Panel
			Maine Molecular Quality Controls, Inc.
			K173171FILMARRAY RESPIRATORY PANEL 2 PLUS (RP2PLUS)
			BIOFIRE DIAGNOSTICS, LLC
			DEN170017Panther Fusion AdV/HMPV/RV Assay
			Hologic, Inc.
			K172629Panther Fusion Paraflu Assay
			Hologic, Inc.
			K172282Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther
			Hologic, Inc.
			K171963Solana RSV+HMPV Assay
			Quidel Corporation
			K171974ID NOW Influenza A & B 2
			Alere Scarborough, Inc.
			K190204ID NOW Influenza A & B 2
			Abbott Diagnostics Scarborough, Inc.
			K191534K220801Cobas Influenza A/B Nucleic Acid Test For Use On The Cobas Liat System
			Roche Molecular Systems, Inc
			K191729COBAS INFLUENZA A/B & RSV NUCLEIC ACID TEST FOR USE ON THE COBAS LIAT SYSTEM
			Roche Molecular Systems, Inc
			K210234K213822FluChip-8G Influenza A+B Assay
			InDevR, Inc
			K182513Cdc 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
			K190302cobas 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
			K200065Simplexa 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.
			K173932ALERE I INFLUENZA A & B, ALERE I STREP A, ALERE I RSV, ALERE I INFLUENZA A & B 4
			Alere Scarborough, Inc.
			K173932ALERE 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
			K131706BDProbetec ET Mycobacterium tuberculosis complex culture identification kit
			Becton, Dickinson, & Co.
			K000884Amplified Mycobacterium tuberculosis Direct Test
			Gen-Probe, Inc.
			P940034Amplicor Mycobacterium tuberculosis test
			Roche Molecular Systems, Inc.
			P940040SNAP M.tuberculosis complex
			Syngene, Inc.
			K900292Accuprobe Mycobacterium tuberculosis complex Test
			Gen-Probe, Inc.
			K896493Rapid Diagnostic System for Mycobacterium tuberculosis
			Gen-Probe, Inc.
			K871795Rapid Identification Test for Mycobacterium tuberculosis complex
			Gen-Probe, Inc.
			K862614*Mycobacterium species*
			Accuprobe Mycobacterium avium complex culture
			Gen-Probe, Inc.
			K921435, K896494, K897078Accuprobe Mycobacterium kansasii Identification Test
			Gen-Probe, Inc.
			K904463SNAP Mycobacterium avium complex
			Syngene, Inc.
			K900202Accuprobe Mycobacterium intracellulare Culture Identification Test
			Gen-Probe, Inc.
			K897077Accuprobe Mycobacterium gordonae culture identification Test
			Gen-Probe, Inc.
			K896492Rapid Diagnostic System for Mycobacterium gordonae
			Gen-Probe, Inc.
			K890089Rapid Diagnostic System for Mycobacteria
			Gen-Probe, Inc.
			K864597Rapid Identification Test for Mycobacterium avium
			Gen-Probe, Inc.
			K862613Gen-Probe Mycobacterium Rapid Confirmation System
			Gen-Probe, Inc.
			K860782*Mycoplasma Genitalium*
			Aptima Mycoplasma Genitalium Assay
			Hologic, Inc.
			DEN180047Mycoplasma 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.
			K160829illumigene Mycoplasma DNA Amplification Assay
			Meridian Bioscience, Inc.
			K152800, K123423Multiplex Panel
			BD Max Vaginal Panel, BD MAX Instrument
			GeneOhm Sciences Canada
			DEN160001/ DEN160001/S001BD MAX Enteric Parasite Panel
			Becton, Dickinson and Company
			K220193BIOCODE GASTROINTESTINAL PATHOGEN PANEL (GPP)
			APPLIED BIOCODE, INC.
			K180041BioFire Blood Culture Identification 2 (BCID2) Panel
			BioFire Diagnostics, LLC
			K193519BioFire Joint Infection (JI) Panel
			BioFire Diagnostics, LLC
			DEN200066FilmArray BCID2 Control Panel M416
			Maine Molecular Quality Controls, Inc.
			K200010Curetis Unyvero LRT Application
			Curetis GmbH
			DEN170047Unyvero LRT BAL Application
			Curetis GmbH
			K191967ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
			GenMark Diagnostics, Inc
			K213236ePlex instrument (multiplex)
			GenMark Diagnostics, Inc
			K163652, K163652/S001FilmArray BCID Panel
			BioFire Defense, LLC
			K143171, K160457FilmArray NGDS Warrior Panel
			BioFire Defense, LLC
			K170883, DEN160048FilmArray Warrior Control Panel
			Maine Molecular Quality Controls, Inc.
			K163522NEUMODX GBS ASSAY
			NEUMODX MOLECULAR, INC.
			K173725PANNAT STEC TEST
			MICRONICS, INC
			K173330ProGastro SSCS Assay
			Gen-Probe Prodesse, Inc.
			K123274Biocode Gastrointestinal Pathogen Panel (GPP)
			Applied Biocode, Inc.
			K190585EntericBio Dx Assay
			Serosep, Ltd.
			K182703xTAG Gastrointestinal Pathogen Panel (GPP)
			Luminex Molecular Diagnostics, Inc.
			K121894K121454BD MAX Extended Enteric Bacterial Panel, BD MAX System
			Becton Dickinson and Company
			K170308K214122BD MAX ENTERIC VIRAL PANEL, BD MAX INSTRUMENT
			Becton Dickinson and Company
			K181427K220607FILMARRAY GASTROINTESTINAL (GI) PANEL
			BIOFIRE DIAGNOSTICS
			K140407, K160459, K160459/S001xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
			Luminex Molecular Diagnostics, Inc.
			K191160xTAG Gastrointestinal Pathogen Panel (GPP)
			Luminex Molecular Diagnostics, Inc.
			K191161T2BACTERIA PANEL
			T2 BIOSYSTEMS, INC.
			K172708xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
			Luminex Molecular Diagnostics, Inc.
			K191160xTAG Gastrointestinal Pathogen Panel (GPP)
			Luminex Molecular Diagnostics, Inc.
			K191161Great Basin Stool Bacterial Pathogens Panel
			Great Basin Scientific, Inc.
			K163571, K163571/S001XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS
			LUMINEX MOLECULAR DIAGNOSTICS INC.
			K140377, K140647VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP)
			NANOSPHERE, INC
			K140083, K142033FILMARRAY PNEUMONIA PANEL
			BioFire Diagnostics, LLC
			K180966FILMARRAY PNEUMONIA PANEL PLUS
			BioFire Diagnostics, LLC
			K181324K222601Multiplex 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
			DEN070001K181205K221658K221834K222558Non-viral microorganism(s) causing sexually transmitted infections
			Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (Instrument And Software), Rheonix Urine Specimen Collection Kit
			Rheonix, Inc
			K193081Visby Medical Sexual Health
			Visby Medical
			K200748*Norovirus*
			RIDA GENE Nororvirus GI/GII
			R-Biopharm AB
			K171511XPERT 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/S001Respiratory panel
			BIOFIRE SPOTFIRE Respiratory (R) Panel
			BioFire Diagnostics, LLC
			K213954BIOFIRE SPOTFIRE Respiratory (R) Panel Mini
			BioFire Diagnostics, LLC
			K230719QIAstat-Dx Respiratory Panel; QIAstat-Dx Analyzer
			QIAGEN GmbH
			K183597FilmArray Pneumonia Panel
			BioFire Diagnostics, LLC
			K212727Respiratory panel control material
			Cepheid Xpert Respiratory Control Panel
			Microbiologics, Inc.
			K190086BioFire 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
			K170940SARS-CoV-2 respiratory infection and other microbial agents
			BioFire COVID-19 Test 2
			BioFire Defense, LLC
			K211079K221460Cobas Sars-Cov-2 Qualitative For Use On The Cobas 6800/8800 Systems
			Roche Molecular Systems, Inc.
			K213804Simplexa COVID-19 Direct
			DiaSorin Molecular LLC
			K212147*Sepsis*
			SeptiCyte LAB
			Immunexpress, Inc.
			K163260*Staphylococcus*
			BD Max MRSA Assay
			BD Diagnostics (GeneOhm Sciences Canada, Inc.)
			K120138Staphylococcus QuickFISH BC
			AdvanDx, Inc.
			K113371MRSA/SA ELITe MGB
			EliTechGroup Epoch Biosciences.
			K112937, K132468Verigene Staphylococcus Blood Culture (BC-S) Nucleic Acid Test
			Nanosphere, Inc.
			K112424NucliSENS EasyQ MRSA Assay
			bioMerieux, Inc.
			K102740Xpert MRSA/SA Blood Culture Assay
			Cepheid
			K101879, K082140Xpert MRSA/SA Nasal Complete Assay
			Cepheid
			K100822LightCycler MRSA Advanced Test
			Roche Molecular Systems, Inc
			K091409BD GeneOhm MRSA ACP Assay
			BD Diagnostics (GeneOhm Sciences Canada, Inc.)
			K093346S. aureus and/or other Staphylococcus species PNA FISH Culture
			AdvanDx, Inc.
			K092166Xpert MRSA/SA SSTI Assay
			Cepheid
			K080837BD GeneOhM StaphSR Assay
			BD Diagnostics (GeneOhm Sciences Canada, Inc.)
			K071026S. aureus PNA FISH
			AdvanDx, Inc.
			K091827, K060099Xpert MRSA
			Cepheid
			K070462IDI-MRSA Assay
			Infectio Diagnostic, Inc.
			K042357, K033415MECA XPRESSFISH
			ADVANDX INC.
			K140619COBAS MRSA/SA TEST
			ROCHE MOLECULAR SYSTEMS INC.
			K142721Xpert MRSA NxG
			Cepheid
			K162444Xpert 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.
			K191172Cepheid Xpert SA Nasal Complete Control Panel
			Microbiologics, Inc.
			K191168*Streptococci*
			ARIES GBS Assay
			Luminex Corporation
			K162772Xpert GBS LB Assay
			Cepheid
			K121539Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
			Cepheid
			K203429illumigene Group A Streptococcus (GBS) DNA Amplification Assay
			Meridian Bioscience, Inc.
			K122019illumigene Group B Streptococcus (GBS) DNA Amplification Assay
			Meridian Bioscience, Inc.
			K121044BD Max GBS Assay
			Becton, Dickinson, & Co.
			K111860Cepheid Smart GBS Assay
			Cepheid
			K062948Xpert GBS
			Cepheid
			K060540IDI-Strep B Assay
			Infectio Diagnostic, Inc.
			K022504Gen-Probe Accuprobe Group B Streptococcus culture identification kit
			Chugai Pharmaceuticals Co, Ltd.
			K974572Accuprobe Streptococcus pneumoniae culture confirmation
			Gen-Probe, Inc.
			K902908ILLUMIGENE GROUP B STREPTOCOCCUS (GBS) DNA AMPLIFICATION ASSAY
			MERIDIAN BIOSCIENCE, INC.
			K112125AMPLIVUE GBS ASSAY
			QUIDEL CORPORATION
			K133503LYRA DIRECT STREP ASSAY
			QUIDEL CORPORATION
			K133883 (DEN140005)AMPLIVUE GAS ASSAY
			QUIDEL CORPORATION
			K141173LIAT STREP A ASSAY
			IQUUM INC
			K141338revogene
			GenePOC Inc.
			K170558GenePOC GBS LB
			GenePOC Inc.
			K170557Solana Strep Complete Assay
			Quidel Corporation
			K162274ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit
			Luminex Corporation
			K172402Xpert Xpress Strep A
			Cepheid
			K172126; K173398GenePOC Strep A
			GenePOC Inc.
			K183366Streptococci / 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.
			K923133Amplivue Trichomonas Assay
			Quidel Corporation
			K143329APTIMA Trichomonas vaginalis (ATV) Assay
			Gen-Probe, Inc.
			K102911APTIMA Trichomonas vaginalis Assay (PANTHER System)
			Gen-Probe, Inc.
			K122062BD ProbeTec Trichomonas vaginalis  (TV) QX Amplified DNA Assay
			Becton, Dickinson & Co.
			K130268Solana Trichomonas Assay
			Quidel Corporation
			K161182, K161182/S001Xpert TV
			Cepheid
			K151565, K151565/S001, K161619Aptima 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
			DEN170029Vaginal Panel (Bacterial vaginosis vaginitis)
			BD Vaginal Panel
			Becton, Dickinson And Company
			K223653BD MAX Vaginal Panel
			GeneOhm Sciences Canada, Inc. (BD Diagnostics)
			DEN160001BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit
			GeneOhm Sciences Canada, Inc. (BD Life Sciences)
			K201017Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
			Cepheid
			K212213K221160Varicella-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

                                                                                  Content current as of:
      05/26/2023
              
              
Regulated Product(s)
		 Medical DevicesIn Vitro Diagnostics

          
                        Companion Diagnostics
          Biotin Interference with Troponin Lab Tests - Assays Subject to Biotin Interference
          Direct-to-Consumer Tests
          Nucleic Acid Based Tests


                        Blood Glucose Monitoring Devices
          Drugs of Abuse Tests
          Home Use Tests
          Laboratory Developed Tests
          Precision Medicine
          Tests Used In Clinical Care
          Warfarin INR Test Meters
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop