BEUDAMED
    Product Code: GST FDA class 2 21 CFR 866.3415

    Antiserum, Pseudomonas Pseudomallei

    Microbiology

    The Antiserum, Pseudomonas Pseudomallei is a laboratory antiserum used in serological assays to identify Pseudomonas pseudomallei (Burkholderia pseudomallei), the bacterial agent of melioidosis, in patient specimens. As an FDA Class 2 device, it carries moderate risk and requires 510(k) premarket clearance. Regulated under 21 CFR 866.3415 with product code GST in the Microbiology specialty. No special flags apply to this device.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    GST
    Device Class
    FDA class 2
    Regulation Number
    866.3415
    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