BEUDAMED
    Product Code: MVE FDA class 2 21 CFR 866.5680

    Biosensor, Immunoassay, Myoglobin

    Immunology

    A Myoglobin Immunoassay Biosensor is an in vitro diagnostic device that uses biosensor technology combined with immunoassay methods to rapidly measure myoglobin levels in blood, used as an early cardiac biomarker following acute myocardial infarction or muscle injury. It is FDA Class 2, requiring 510(k) clearance, with product code MVE under 21 CFR 866.5680 in the Immunology specialty. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    MVE
    Device Class
    FDA class 2
    Regulation Number
    866.5680
    Medical Specialty
    Immunology
    Review Panel
    IM
    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
    K981536 QUANTECH MYOGLOBIN ASSAY

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.