BEUDAMED
    Product Code: DGW FDA class 2 21 CFR 866.5500

    System, Test, Hypersensitivity Pneumonitis

    Immunology

    The Hypersensitivity Pneumonitis Test System is a diagnostic test used in clinical laboratories to detect specific antibodies associated with hypersensitivity pneumonitis, an inflammatory lung condition caused by repeated inhalation of organic dust or other antigens. It is classified as FDA Class 2, a moderate-risk designation requiring 510(k) premarket notification, and is regulated under 21 CFR 866.5500 within the Immunology specialty. The device is eligible for third-party 510(k) review.

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

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    Basic Information

    Product Code
    DGW
    Device Class
    FDA class 2
    Regulation Number
    866.5500
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    1

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.