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

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·cobas® EZH2 Mutation Test

    Somatic Gene Mutation Detection System

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

    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 and cobas EGFR Mutation Test v2

    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 ·THERASCREEN KRAS RGQ PCR KIT

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Abbott RealTime IDH1, Abbott RealTime IDH1 Amplification Reagent Kit, Abbott RealTime IDH1 Control Kit, Abbott RealTime

    Somatic Gene Mutation Detection System

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

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·cobas® BRAF V600 Mutation Test

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·COBAS 4800 BRAF V600 MUTATION TEST

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·ROCHE COBAS 4800 BRAF V600 MUTATION TEST

    Somatic Gene Mutation Detection System

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

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·QIAGEN THERASCREEN EGFR RGQ PCR KIT

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·COBAS 4800 BRAF V600 MUTATION TEST

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Roche cobas DNA Sample Preparation Kit, Roche cobas 4800 BRAF V600 Mutation Test

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·THXID-BRAF KIT

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Roche cobas KRAS Mutation Test, Roche cobas DNA Sample Preparation Kit

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·LeukoStrat® CDx FL T3 Mutation Assay