Resources for Food and Drug Administration (FDA)
FDA Clears First Automated Whole Blood Processing System In U.S.
www.medicalnewstoday.com Gambro BCT, Inc., soon to be known as CaridianBCT, a leading global provider of technology, products and services in automated blood collections, therapeutic systems, whole blood processes and pathogen reduction technologies, announced that it received FDA clearance for the commercial sale of AtreusŪ Whole Blood Processing system in the United States. The Atreus system is the first self-contained, automated manufacturing system cleared for distribution in the U.S.
The Atreus system includes both automation and informatics capabilities. The Atreus device automates the manufacturing process of a unit of whole blood. Replacing balances, centrifuges, expressers, sealers, and scales, the Atreus system significantly reduces variability from the manufacturing process. In the future, the company also will distribute specialized tubing kits, including a single collect bag and a compatible processing kit. The initial offering allows blood centers to leukoreduce the Red Blood Cell unit by gravity filtration after processing.
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