BEUDAMED
    Product Code: QZH FDA class 3

    Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

    Unknown

    The opioid use disorder genetic risk variant detection system and collection kit (product code QZH) is a Class 3 in vitro molecular diagnostic device reviewed by the Clinical Toxicology panel, intended to qualitatively detect select variants in genomic DNA from human specimens to provide a genetic risk assessment of developing opioid use disorder (OUD) and aid users in making informed decisions regarding oral opioid use for acute pain relief. As a Class 3 device, it requires PMA. The test is not intended to describe an individual's overall risk of OUD or to serve as the sole determinant in diagnosing, counseling, or prescribing decisions, and must be used in combination with clinical information.

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

    Research product code QZH 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
    QZH
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    TX
    Submission Type
    2

    Device Characteristics

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

    Definition

    A qualitative in vitro molecular test that detects select variants in genomic DNA isolated from human specimens. Results of the test provide users with a genetic risk assessment of developing Opioid Use Disorder (OUD) and are intended to aid users with informed decision-making regarding the use of oral opioids for acute pain relief. The test may not include all variants associated with a risk of developing OUD and is not intended to describe a person’s overall risk of developing OUD. Results from the system are intended to be used in combination with clinical information and should not be the sole determinant in diagnosing, counseling, or making prescribing decisions

    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.