BEUDAMED
    Product Code: LJD FDA class 2 21 CFR 864.5220

    Assay, B Lymphocyte Marker

    Hematology

    A B lymphocyte marker assay is a laboratory hematology test used to identify and enumerate B lymphocytes by detecting characteristic cell-surface antigens, supporting the evaluation of humoral immunity, the diagnosis of B-cell lymphoproliferative disorders, and immune monitoring in transplantation. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It carries product code LJD and is regulated under 21 CFR 864.5220 within the Hematology specialty. This device is eligible for third-party review.

    View on FDA
    510(k)s
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    LJD
    Device Class
    FDA class 2
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    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
    K851639 ANTI-LEU-12 B CELL REAGENT

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.