BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

    PMA: P190033 · Supplement: S001 · Decision Oct 4, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors
    Trade Name
    AAV5 DetectCDx®
    PMA Number
    P190033
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    QWQ
    Generic Name
    Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors
    Medical Specialty
    Unknown
    Advisory Committee
    Hematology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 4, 2024
    Date Received
    September 5, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    To change the scale of size exclusion chromatography, and accept SULFO-TAG AAV5 Capsid below previously-defined method acceptance criteria.

    Classifications

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

    Product Code Device Name
    QWQ Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors