BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Cytomegalovirus (Cmv) Dna Quantitative Assay

    PMA: P130027 · Supplement: S002 · Decision Jun 2, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Cytomegalovirus (Cmv) Dna Quantitative Assay
    Trade Name
    ARTUS CMV RGQ MDX KIT
    PMA Number
    P130027
    Supplement Number
    S002
    Device Class
    FDA Class 2
    Product Code
    PAB
    Generic Name
    Cytomegalovirus (cmv) dna quantitative assay
    Regulation Number
    866.3180
    Medical Specialty
    Microbiology
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 2, 2017
    Date Received
    November 14, 2016
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval to expand the use of the artus CMV RGQ MDx assay system to include the QIAsymphony RGQ MDx system. The new assay system includes the QIAsymphony SP instrument and QIAsymphony DSP Virus/Pathogen Kit for automated sample preparation, automated assay setup on the QIAsymphony AS, artus CMV QS­ RGQ MDx Kit, and Rotor-Gene Q MDx instrument with Rotor-Gene AssayManager v1.0 software.

    Classifications

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

    Product Code Device Name
    PAB Cytomegalovirus (Cmv) Dna Quantitative Assay