BEUDAMED
    Product Code: QWQ FDA class 3

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

    Unknown

    The assay to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors (product code QWQ) is a Class 3 in vitro diagnostic device reviewed by the Immunology panel, intended to detect and/or measure pre-existing endogenous antibodies to AAV viral vectors in patients who may receive AAV vector-based gene therapy products. As a Class 3 device, it requires PMA. No regulation number has been assigned. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
    —

    Research product code QWQ in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    QWQ
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    IM
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    An in vitro diagnostic device intended to detect and/or measure pre-existing endogenous antibodies to adeno-associated virus (AAV) viral vectors in patients who may receive AAV vector-based gene therapy products.

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.