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

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·therascreen EGFR RGQ PCR kit

    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 ·therascreen EGFR RGQ PCR Kit

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Abbott RealTime IDH1

    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 ·cobas® EZH2 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 ·COBAS 4800 BRAF V600 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® KRAS Mutation Test

    Electrosurgical, Radio Frequency, Refractive Correction

    FDA Pre-Market Approval
    FDA Class 3 ·VIEWPOINT CK SYSTEM (KERATOPLAST TIP COMPONENT)

    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 ·cobas BRAF V600 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 BRAF V600 Mutation Test

    Continuous Glucose Monitor, Implanted, Adjunctive Use

    FDA Pre-Market Approval
    FDA Class 3 ·Eversense Continuous Glucose Monitoring System

    Somatic Gene Mutation Detection System

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

    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 ·cobas KRAS Mutation Test

    Somatic Gene Mutation Detection System

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