BEUDAMED
    Product Code: MZI FDA unclassified

    Test, Qualitative, For Hla, Non-Diagnostic

    Unknown

    The Qualitative HLA Test for Non-Diagnostic Use is an in vitro device used to qualitatively detect Human Leukocyte Antigen (HLA) markers for non-diagnostic applications such as blood banking and transplant compatibility screening. This product code (MZI) has an unclassified regulatory status (class "U") indicating it has been reviewed but not formally assigned to a device class. The unclassified reason code 1 applies. It is reviewed by the Hematology panel.

    View on FDA
    510(k)s
    0
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MZI
    Device Class
    FDA unclassified
    Medical Specialty
    Unknown
    Review Panel
    HE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Unclassified Reason

    1

    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.