BEUDAMED
    1,610 results · 21ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

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

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne CDx (F1CDx)

    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 ·FoundationOne CDx (F1CDx)

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·THINPREP PROCESSORS

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

    FDA Pre-Market Approval
    FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAYANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

    Immunohistochemistry Antibody Assay, C-Kit

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY

    Reader, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·THINPREP IMAGING SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne Liquid CDx (F1 Liquid CDx)

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

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

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

    FDA Pre-Market Approval
    FDA Class 3 ·Guardant360 CDx

    Somatic Gene Mutation Detection System

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

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

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne CDx

    System, Test, Her-2/Neu, Ihc

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

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

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

    System, Test, Her-2/Neu, Ihc

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

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

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

    Prostrate Cancer Genes Nucleic Acid Amplification Test System

    FDA Pre-Market Approval
    FDA Class 3 ·PROGENSA PCA3 ASSAY

    Immunohistochemistry Antibody Assay, C-Kit

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY

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

    FDA Pre-Market Approval
    FDA Class 3 ·HER2FISH PHARMDX KIT