BEUDAMED
    Product Code: DBT FDA class 1 21 CFR 866.5330

    Factor Xiii A, S, Antigen, Antiserum, Control

    Immunology

    This is an immunological reagent kit for detecting Factor XIII subunits (A and S), the transglutaminase that cross-links fibrin to stabilize blood clots, including antigen, antiserum, and control components for clinical laboratory immunoassays. Factor XIII deficiency is associated with impaired wound healing and excessive bleeding. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is DBT, regulated under 21 CFR 866.5330, within the Immunology specialty.

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    510(k)s
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    DBT
    Device Class
    FDA class 1
    Regulation Number
    866.5330
    Medical Specialty
    Immunology
    Review Panel
    HE
    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
    K872230 MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE

    FEI Numbers

    This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.