BEUDAMED
    Product Code: QCH FDA class 2 21 CFR 866.3920

    Assayed Quality Control Material For Clinical Microbiology Assays

    Microbiology

    The Assayed Quality Control Material For Clinical Microbiology Assays consists of serologic controls used with microbiology assays to verify assay performance and ensure accurate test results in clinical laboratory settings. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is QCH under regulation 866.3920 in the Microbiology specialty. It is not an implant and is not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    QCH
    Device Class
    FDA class 2
    Regulation Number
    866.3920
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

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

    Definition

    Serologic controls for microbiology assays

    FEI Numbers

    This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.