BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Cytomegalovirus (Cmv) Dna Quantitative Assay

    PMA: P210022 · Supplement: S008 · Decision Jan 16, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Cytomegalovirus (Cmv) Dna Quantitative Assay
    Trade Name
    Alinity m CMV
    PMA Number
    P210022
    Supplement Number
    S008
    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
    January 16, 2024
    Date Received
    October 18, 2023
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a change of the Alinity m CMV Assay to implement a new application specification file containing an improved PCR reagent assembly process that mitigates the potential for overflow at the Alinity m Amplification (AMP) Tray, thus minimizing the potential risk for carryover. The Alinity m CMV Kit package insert is also being updated to reflect the carryover rate using the new application specification file.

    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