BEUDAMED
    Product Code: DDY FDA class 2 21 CFR 866.5620

    Alpha-2-Macroglobulin, Fitc, Antigen, Antiserum, Control

    Immunology

    This is an immunological reagent kit for detecting alpha-2-macroglobulin, a broad-spectrum protease inhibitor in human plasma that also functions as a cytokine carrier, using FITC as a fluorescent conjugate, including antigen, antiserum, and control components for immunofluorescence-based analysis. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is DDY, regulated under 21 CFR 866.5620, within the Immunology specialty.

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

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    Basic Information

    Product Code
    DDY
    Device Class
    FDA class 2
    Regulation Number
    866.5620
    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
    K790710 ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN

    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.