BEUDAMED
    Product Code: MCS FDA class 1 21 CFR 866.3700

    Dna-Probe, Staphylococcus Aureus

    Microbiology

    The Staphylococcus aureus DNA probe is a microbiology in vitro diagnostic device that uses nucleic acid hybridization to detect S. aureus in clinical specimens, supporting rapid identification of this bacterium associated with a wide range of infections. It is classified as FDA Class I under 21 CFR 866.3700 within the Microbiology specialty, subject only to general controls. The product code is MCS and the device is not GMP-exempt. It is not implanted and does not sustain life.

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

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    Basic Information

    Product Code
    MCS
    Device Class
    FDA class 1
    Regulation Number
    866.3700
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    4

    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
    K902213 ACCUPROBE STAPHYLOCOCCUS AUREUS CULTURE CONFIRMA.