BEUDAMED
    Product Code: KTM FDA class 2 21 CFR 866.5240

    C3-Indirect Immunofluorescent Solid Phase

    Immunology

    The C3 Indirect Immunofluorescent Solid Phase device is an in vitro diagnostic system used to detect complement component C3 in patient samples, supporting evaluation of complement pathway activity in autoimmune and inflammatory conditions. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KTM, regulated under 21 CFR 866.5240, in the Immunology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

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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
    KTM
    Device Class
    FDA class 2
    Regulation Number
    866.5240
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    1

    Device Characteristics

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