BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

    PMA: P230032 · Supplement: S004 · Decision Apr 10, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit
    Trade Name
    AvertD and AvertD Buccal Sample Collection Kit
    PMA Number
    P230032
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    QZH
    Generic Name
    Opioid use disorder genetic risk variant detection system and collection kit
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Toxicology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 10, 2026
    Date Received
    January 9, 2026
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of venous whole blood as sample type for use with the AvertD test.

    Classifications

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

    Product Code Device Name
    QZH Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit