Device Dossier

Immunohistology cell marker IVDs

Device Dossier for Immunohistology cell marker IVDs (CT1056 - Immunohistology cell marker IVDs, Class 2, sponsor STEMCELL Technologies (Australia)…

Intended purpose

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.

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