May 2024—Stemcell Technologies announced that the FDA has granted de novo classification for its immunomagnetic plasma cell enrichment kit. The EasySep Human Bone Marrow CD138 Positive Selection kit, for in vitro diagnostic applications, is intended to enrich CD138 positive plasma cells from bone marrow samples collected from patients with multiple myeloma, as part of a preanalytical workflow. Commercial launch of the kit is planned in the European Union, Canada, the United Kingdom, and the United States.
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