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news.BioE has received 510(k) clearance from the FDA for its PrepaCyte-CB processing system for umbilical cord blood.
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PrepaCyte-CB provides public and private cord blood banks a simple and cost-effective method for processing umbilical cord blood to obtain potentially therapeutic cells – total nucleated cells and CD34+ hematopoietic stem/progenitor cells – for eventual transplantation in humans, the company said.
Gayl Chrysler, vice president of cellular therapies and clinical affairs at BioE, said: “We are excited about PrepaCyte-CB’s ability to improve the quality and bankability of cord blood units during a time of rapid growth for cord blood utilization in transplantation.”