BEUDAMED
    Product Code: NCD FDA class 3

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    Unknown

    The Cell-Mediated Immunity Test for Mycobacterium Tuberculosis is an in vitro diagnostic device used to detect cell-mediated immune responses to Mycobacterium tuberculosis antigens, such as interferon-gamma release assays (IGRAs), as an alternative to the tuberculin skin test for diagnosing latent and active tuberculosis infection. Classified as FDA Class 3, it requires Premarket Approval (PMA) due to the public health significance of tuberculosis diagnostics. It is reviewed by the Microbiology panel.

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

    Basic Information

    Product Code
    NCD
    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

    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.