NEW YORK (360Dx) – The US Food and Drug Administration today provided CLIA waiver to Sysmex America's automated analyzer for common blood cell count.

The XW-100 Automated Hematology Analyzer was previously granted 510(k) clearance by the FDA in 2015 for use at the point of care. With the CLIA waiver, the test can be run in additional healthcare settings — including doctors' offices, clinics, and other healthcare facilities — and by a wider range of support staff, the FDA said.

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