Beckman files 510(k) for Early Sepsis Indicator

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October 2018—Beckman Coulter filed a submission for 510(k) clearance with the FDA for its Early Sepsis Indicator, offered as part of a standard CBC with differential test. As such, test results can be available in less than one hour. The Early Sepsis Indicator, which recently achieved CE marking, is available in select countries for use with the company’s DxH 900 hematology analyzer.