BEUDAMED
    Product Code: DFF FDA class 2 21 CFR 866.5080

    Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control

    Immunology

    This is an immunological reagent kit for detecting alpha-1-antichymotrypsin, a serine protease inhibitor in the serpin superfamily that is an acute-phase reactant and inhibitor of chymotrypsin-like proteases, including antigen, antiserum, and control components for clinical immunoassay testing. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification, and is eligible for third-party review. The product code is DFF, regulated under 21 CFR 866.5080, within the Immunology specialty.

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

    Basic Information

    Product Code
    DFF
    Device Class
    FDA class 2
    Regulation Number
    866.5080
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    1

    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
    K863868 IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT