BEUDAMED
    Product Code: QSS FDA class 3

    Hiv Self-Tests

    Unknown

    HIV Self-Tests are in vitro diagnostic devices intended for individual, self-administered testing for the presence of human immunodeficiency virus (HIV) in body fluids, allowing users to determine their HIV status without requiring a healthcare provider to administer the test. Due to the high-risk implications of a false result and the self-use context, these devices are classified as FDA Class 3 requiring Premarket Approval (PMA). They are reviewed under the Microbiology panel and carry no implant or life-sustaining flags. No regulation number is assigned.

    View on FDA
    510(k)s
    0
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    QSS
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    MI
    Submission Type
    2

    Device Characteristics

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

    Definition

    Human immunodeficiency virus (HIV) self-tests are intended for use by an individual to test themselves for the presence of HIV in body fluids.

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.