BEUDAMED
    Product Code: DGX FDA class 1 21 CFR 866.5065

    Ng1m(A), Antigen, Antiserum, Control

    Immunology

    The Ng1m(A) Antigen, Antiserum, and Control is an immunological reagent used to detect and characterize the Ng1m(a) allotypic marker on immunoglobulin molecules, supporting research and clinical testing related to immunoglobulin genetics and immune function. It is classified as FDA Class 1, indicating low risk, and is subject only to general controls without a premarket notification requirement. The device is regulated under 21 CFR 866.5065 within the Immunology specialty.

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

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    Basic Information

    Product Code
    DGX
    Device Class
    FDA class 1
    Regulation Number
    866.5065
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    4

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K841114 ALLO-TYPE HUMAN IMMUNOGLOBULIN-