BEUDAMED
    Product Code: MWB FDA class 3

    Kit, Test, Saliva, Hiv-1&2

    Unknown

    An HIV-1 and HIV-2 Saliva Test Kit is an in vitro diagnostic device that detects antibodies to HIV-1 and HIV-2 in oral fluid samples, providing a non-invasive alternative to blood-based HIV screening tests. It is classified as FDA Class 3, requiring PMA approval, with product code MWB. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
    —

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

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.