BEUDAMED
    Product Code: GSW FDA class 1 21 CFR 866.3270

    Antiserum, Flavobacterium Meningosepticum, All Groups

    Microbiology

    The Antiserum, Flavobacterium Meningosepticum, All Groups is a laboratory antiserum used in serological testing to identify Flavobacterium meningosepticum (now Elizabethkingia meningoseptica) across all antigenic groups, a bacterium associated with meningitis in neonates and immunocompromised patients. It is an FDA Class 1 device subject to general controls only, requiring no premarket notification. The product code is GSW, regulated under 21 CFR 866.3270 in the Microbiology specialty. No special flags apply to this device.

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    Basic Information

    Product Code
    GSW
    Device Class
    FDA class 1
    Regulation Number
    866.3270
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    4

    Device Characteristics

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