BEUDAMED
    171 results · 16ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    System, Test, Her-2/Neu, Nucleic Acid Or Serum

    FDA classification
    FDA Class 3 ·System, Test, Her-2/Neu, Nucleic Acid Or Serum

    Immunohistochemistry Assay, Antibody, Met

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

    Immunohistochemistry Assay, Antibody, Claudin 18

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA CLDN18 (43-14A) RxDx Assay

    Immunohistochemistry Assay, Antibody, Folr1

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

    Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·INFORM HER2 DUAL ISH DNA PROBE COCKTAIL

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

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

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

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

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

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

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