BEUDAMED
    1,822 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·therascreen® KRAS RGQ PCR Kit

    Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA ALK (D5F3) CDx Assay

    Prostrate Cancer Genes Nucleic Acid Amplification Test System

    FDA Pre-Market Approval
    FDA Class 3 ·Progensa PCA3 Assay

    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Cologuard

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·PREPSTAIN SYSTEM

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·COBAS KRAS MUTATION TEST

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·cobas EGFR Mutation Test v2

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·cobas EGFR Mutation Test and cobas EGFR Mutation Test v2

    System, Test, Tumor Marker, For Detection Of Bladder Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·UroVysion Bladder Cancer Kit

    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Cologaurd

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·PD-L1 IHC 22C3 PHARMDX

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

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne Liquid CDx (F1LCDx)

    Immunocytochemistry Assay, P16/Ki-67

    FDA Pre-Market Approval
    FDA Class 3 ·CINtec PLUS Cytology

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA PD-L1 (SP142) Assay

    Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

    FDA Pre-Market Approval
    FDA Class 3 ·UroVysion Bladder Cancer Kit

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·cobas EGFR Mutation Test v2

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA PD-Ll (SP142) Assay

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Cologuard

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·cobas KRAS Mutation Test