BEUDAMED
    Product Code: DDN FDA class 1 21 CFR 866.5430

    Beta-2-Glycoprotein I, Antigen, Antiserum, Control

    Immunology

    This is an immunological reagent kit for detecting beta-2-glycoprotein I (also known as apolipoprotein H), a phospholipid-binding plasma protein that is a major antigenic target in antiphospholipid syndrome, including antigen, antiserum, and control components for clinical immunoassay use. It is classified as FDA Class 1, the lowest risk category, subject to general controls only and not requiring premarket notification. The product code is DDN, regulated under 21 CFR 866.5430, within the Immunology specialty.

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

    Product Code
    DDN
    Device Class
    FDA class 1
    Regulation Number
    866.5430
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.