BEUDAMED
    Product Code: DEN FDA class 1 21 CFR 866.5420

    Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control

    Immunology

    This is an immunological reagent kit for detecting alpha-1-T-glycoprotein, a plasma protein classified within the alpha-1 glycoprotein fraction, including antigen, antiserum, and control components for clinical immunoassay applications in laboratory settings. 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 DEN, regulated under 21 CFR 866.5420, within the Immunology specialty.

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    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    0

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    Basic Information

    Product Code
    DEN
    Device Class
    FDA class 1
    Regulation Number
    866.5420
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K780325 RID SYSTEM-HUMAN C-REACTIVE PROTEIN
    K771879 GLYCOPROTEIN TEST, LAS-R HUMAN 1-ACID