BEUDAMED
    Product Code: LSG FDA class 2 21 CFR 866.3165

    Candida Species, Antibody Detection

    Microbiology

    The Candida Species Antibody Detection device is an in vitro diagnostic reagent used to detect antibodies against Candida species in patient serum, aiding in the serological diagnosis of systemic or invasive candidiasis in immunocompromised or critically ill patients. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification. The product code is LSG, regulated under 21 CFR 866.3165, within the Microbiology medical specialty. No special flags apply to this device.

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    510(k)s
    0
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    LSG
    Device Class
    FDA class 2
    Regulation Number
    866.3165
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.