BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

    PMA: P230032 · Supplement: S001 · Decision Feb 16, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    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
    S001
    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
    February 16, 2024
    Date Received
    January 18, 2024
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P230032.

    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