BEUDAMED
    Product Code: MZE FDA class 2

    Test, Donor, Cmv

    Unknown

    The Donor Cytomegalovirus (CMV) Test is an in vitro diagnostic device used to screen blood donors for cytomegalovirus (CMV) antibodies, enabling the identification of CMV-seronegative blood for transfusion to immunocompromised recipients who are at high risk of CMV disease. Classified as FDA Class 2, it requires 510(k) premarket clearance. This device is reviewed by the Immunology panel.

    View on FDA
    510(k)s
    0
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MZE
    Device Class
    FDA class 2
    Medical Specialty
    Unknown
    Review Panel
    IM
    Submission Type
    1

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.