BEUDAMED
    Product Code: MTN FDA not classified

    Test, Syphilis, Treponemal

    Unknown

    A Treponemal Syphilis Test is a serological in vitro diagnostic device that detects antibodies specific to Treponema pallidum antigens in patient blood, used to confirm syphilis infection following a reactive nontreponemal screening test. This device has no assigned device class (class "N") in the FDA database. The product code is MTN with no regulation number assigned, and the device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MTN
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    HE
    Submission Type
    3

    Device Characteristics

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

    Unclassified Reason

    4

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.