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510(k) Data Aggregation

    K Number
    DEN220090
    Device Name
    EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748)
    Date Cleared
    2023-11-06

    (329 days)

    Product Code
    Regulation Number
    866.6120
    Why did this record match?
    Applicant Name (Manufacturer) :

    STEMCELL Technologies Canada Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    EasySep Human Bone Marrow CD138 Positive Selection Kit is an in vitro diagnostic device intended to enrich CD138+ cells from bone marrow collected from patients diagnosed with multiple myeloma. The CD138+ cells are enriched by immunomagnetic positive selection for use in validated downstream assays. The end-user is responsible for validation of this kit for use with the assay. For in vitro diagnostic use by laboratory professionals.
    Device Description
    The EasySep CD138 Human Bone Marrow CD138 Positive Selection Kit contains reagents to enrich CD138 positive (CD138+) human bone marrow cells. The kit contains reagents for up to 60 mL of bone marrow purifications. The kit contents are listed in Table 1. Materials required but not provided are shown in Table 2.
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