BEUDAMED
    Product Code: DGA FDA class 1 21 CFR 866.5220

    Cohn Fraction Ii, Antigen, Antiserum, Control

    Immunology

    The Cohn Fraction II Antigen, Antiserum, and Control is an immunological reagent derived from Cohn fractionation, a plasma protein purification method, used to detect or characterize albumin and related plasma proteins. It is classified as FDA Class 1, indicating low risk and requiring only general controls without premarket notification. The device is regulated under 21 CFR 866.5220 within the Immunology specialty. No special risk flags apply.

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    Basic Information

    Product Code
    DGA
    Device Class
    FDA class 1
    Regulation Number
    866.5220
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    4

    Device Characteristics

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