BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

    PMA: P130017 · Supplement: S002 · Decision Aug 18, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
    Trade Name
    COLOGUARD
    PMA Number
    P130017
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    PHP
    Generic Name
    System, colorectal neoplasia, DNA methylation and hemoglobin detection
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 18, 2015
    Date Received
    May 20, 2015
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO EXTEND THE SHELF LIFE OF THE COLOGUARD ASSAY REAGENTS(COLOGUARD MOLECULAR ASSAY REAGENTS, COLOGUARD MOLECULAR CONTROLS, COLOGUARD HEMOGLOBIN ASSAY REAGENTS, AND COLOGUARD HEMOGLOBIN CONTROLS), ON THE BASIS OF ADDITIONAL REAL-TIME STABILITY TESTING, FROM A SHELF-LIFE OF SIX (6) MONTHS TO A SHELF-LIFE OF NINE (9) MONTHS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PHP System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection