BEUDAMED
    193 results · 69ms · Sources: EU EUDAMED, US FDA

    QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

    FDA 510(k)
    FDA Class 2 ·Medical Genetics

    ipsogen JAK2 RGQ PCR Kit

    FDA 510(k)
    FDA Class 2 ·Medical Genetics

    MUTYH-Associated Polyposis (MAP)

    FDA 510(k)
    FDA Class 2 ·Medical Genetics

    23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

    FDA 510(k)
    FDA Class 2 ·Medical Genetics

    Helix Laboratory Platform

    FDA 510(k)
    FDA Class 2 ·Medical Genetics

    BCR-ABL1 (p210) % IS Kit (Digital PCR Method)

    FDA 510(k)
    FDA Class 2 ·Medical Genetics

    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

    FDA 510(k)
    FDA Class 2 ·Medical Genetics

    23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

    FDA 510(k)
    FDA Class 2 ·Medical Genetics

    23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)

    FDA 510(k)
    FDA Class 2 ·Medical Genetics

    MRDx BCR-ABL Test, MRDx BCR-ABL Test Software

    FDA 510(k)
    FDA Class 2 ·Medical Genetics

    23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)

    FDA 510(k)
    FDA Class 2 ·Medical Genetics

    23andMe, Inc. Personal Genome Service®(PGS)

    FDA UDI
    23ANDME, INC.·00859462006095·23andMe Personal Genome Service® (PGS) Includes...

    23andMe, Inc. Personal Genome Service®(PGS)

    FDA UDI
    23ANDME, INC.·00859462006118·23andMe Personal Genome Service® (PGS) Includes...

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·therascreen BRAF V600E RGQ PCR Kit

    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Shield

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Agilent Resolution ctDx FIRST

    Immunohistochemistry Assay, Antibody, Folr1

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA FOLR1 (FOLR-2.1) RxDx Assay

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·therascreen FGFR RGQ RT-PCR Kit

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·MI Cancer Seek

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Abbott RealTime IDH1