BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Cytomegalovirus (Cmv) Dna Quantitative Assay

    PMA: P110037 · Supplement: S005 · Decision Mar 21, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Cytomegalovirus (Cmv) Dna Quantitative Assay
    Trade Name
    COBAS AMPLIPREP/COBAS TAQMAN CYTOMEGALOVIRUS TEST
    PMA Number
    P110037
    Supplement Number
    S005
    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
    March 21, 2013
    Date Received
    February 19, 2013
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO THE SOFTWARE TEST DEFINITION FILES.

    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