BEUDAMED
    Product Code: DHI FDA class 1 21 CFR 866.5065

    Ng3m(Bo), Antigen, Antiserum, Control

    Immunology

    The Ng3m(Bo) Antigen, Antiserum, and Control is an immunological reagent used to detect and characterize the Ng3m(bo) allotypic determinant on immunoglobulin molecules, with applications in immunogenetic studies and specialized clinical testing. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and exempt from premarket notification. The device is regulated under 21 CFR 866.5065 within the Immunology specialty.

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

    Research product code DHI 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
    DHI
    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

    Loading...

    Related 510(k) Clearances

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

    K Number Device Name
    K810625 HUMAN PLACENTAL LACTOGEN RADIOIMMUNO-