BEUDAMED
    Product Code: DGH FDA class 2 21 CFR 866.5510

    Igd, Peroxidase, Antigen, Antiserum, Control

    Immunology

    The IgD Peroxidase Antigen, Antiserum, and Control is a peroxidase-conjugated immunological reagent used to detect IgD immunoglobulins in enzyme-linked assays such as ELISA. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 866.5510 within the Immunology specialty. This device qualifies for third-party 510(k) review by an FDA-recognized accredited organization.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    DGH
    Device Class
    FDA class 2
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Review Panel
    PA
    Submission Type
    1

    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
    K812076 ANTI-GM & ANTI-KM TYPING SERUMS