BEUDAMED
    Product Code: GTC FDA class 1 21 CFR 866.3340

    Antisera, All Types, Klebsiella Spp.

    Microbiology

    The Antisera, All Types, Klebsiella Spp. is a collection of type-specific antisera used for the serotyping of Klebsiella species isolates in clinical microbiology laboratories, aiding in epidemiological investigation of Klebsiella infections. It is an FDA Class 1 device, the lowest regulatory risk category, requiring only general controls and no premarket submission. The product code is GTC, regulated under 21 CFR 866.3340 in the Microbiology specialty. No special flags apply to this device.

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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
    GTC
    Device Class
    FDA class 1
    Regulation Number
    866.3340
    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
    K830276 SECURET DRAPE & INSTRUMENT RETAINER/INCL