BEUDAMED
    Product Code: DAF FDA class 2 21 CFR 866.5510

    Gamma Globulin, Fitc, Antigen, Antiserum, Control

    Immunology

    This is an immunological reagent kit for the detection of gamma globulin, the protein fraction of blood serum containing the majority of immunoglobulins, using a FITC-conjugated format. The kit includes antigen, antiserum, and control components for clinical immunology testing. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DAF, regulated under 21 CFR 866.5510, within the Immunology specialty.

    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
    DAF
    Device Class
    FDA class 2
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Review Panel
    IM
    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
    K871027 PRECINORM(R) PROTEIN