BEUDAMED
    Product Code: MVS FDA class 2 21 CFR 866.5660

    Kit, Typing, Hla-Dqb

    Immunology

    An HLA-DQB Typing Kit is a molecular diagnostic device used to identify HLA-DQB alleles (human leukocyte antigen gene variants) through DNA-based typing methods, essential for matching donors and recipients in organ and stem cell transplantation and for disease association studies. It is FDA Class 2, requiring 510(k) clearance, with product code MVS under 21 CFR 866.5660 in the Immunology specialty. The device is not an implant and is not life-sustaining.

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

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    Basic Information

    Product Code
    MVS
    Device Class
    FDA class 2
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Review Panel
    HE
    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
    K020694 QAB2A IGM ELISA KIT