BEUDAMED
    3,791 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·INSITE HER-2/NEU KIT

    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

    Reader, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM

    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 ·HER2 CISH PHARMADX KIT

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·Hercep Test

    Somatic Gene Mutation Detection System

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

    System, Test, Her-2/Neu, Ihc

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

    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

    Somatic Gene Mutation Detection System

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

    Immunocytochemistry Assay, P16/Ki-67

    FDA Pre-Market Approval
    FDA Class 3 ·CINtec PLUS Cytology

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

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

    Somatic Gene Mutation Detection System

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

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

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

    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

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·THINPREP PROCESSOR 2000/3000

    Somatic Gene Mutation Detection System

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

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

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

    Reader, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·BD FOCALPOINT SLIDE PROFILER