BEUDAMED
    Product Code: SBT FDA class 2 21 CFR 866.3967

    Device To Detect Microbial Colonization Directly From Clinical Specimens.

    Microbiology

    A device to detect microbial colonization directly from clinical specimens is a qualitative in vitro diagnostic device intended to detect and identify microbial-associated targets from patients suspected of being colonized with a pathogen that may risk transmission to other patients or healthcare workers, aiding infection prevention and control in healthcare settings when used with other clinical and laboratory findings. It is classified as FDA Class II (510(k) required) under regulation 866.3967 in the Microbiology specialty, with product code SBT. The device is not an implant and does not support life-sustaining functions.

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

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    Basic Information

    Product Code
    SBT
    Device Class
    FDA class 2
    Regulation Number
    866.3967
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

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

    Definition

    A device to detect microbial colonization directly from clinical specimens is a qualitative in vitro diagnostic device intended for the detection and identification of microbial-associated targets from patients who are suspected of being colonized with a microbial pathogen and may present a risk of transmission to other patients and health care workers. This device is intended to aid in the detection of microbial colonizers for the prevention and control of infection in healthcare settings when used in conjunction with clinical and laboratory findings.

    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
    DEN230092 Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.