BEUDAMED
    2,490 results · 29ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: FDA Class 3 ×

    Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA MMR RxDx Panel Solid Tumors with dMMR status)

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·HERCEP TEST

    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Cologuard

    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Cologuard

    Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA ALK (D5F3) CDX ASSAY

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

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA HER2 DualL ISH DNA Probe Cocktail

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·Bond™ Oracle™ HER2 IHC System

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

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

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

    FDA Pre-Market Approval
    FDA Class 3 ·Path Vysion HER-2 DNA Probe Kit

    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Cologuard

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

    FDA Pre-Market Approval
    FDA Class 3 ·URO VYSION BLADDER CANCER KIT

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

    FDA Pre-Market Approval
    FDA Class 3 ·Oncomine Dx Target Test

    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, 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 ·COLOGUARD

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

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA HER2 Dual ISH DNA Probe Cocktail

    Reader, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·BD FocalPoint GS Imaging System

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

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

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·THxID BRAF assay kit

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA PD-L1 (SP263) Assay