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FDA Clears Waived CBC For Near-Patient Testing

Sysmex Granted First-Ever FDA Clearance of a CLIA-Waived CBC Analyzer for Hematology

CEO SUMMARY: Market clearance of the first-ever CLIA-waived analyzer for complete blood count and three-part differential tests could cut time-to-answer from days to mere minutes for one of the top 20 tests by volume performed at core laboratories. Developer Sysmex America, Inc., foresees its analyzer as a complement to central labs. Basic diagnostics would be …

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