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Medical Devices / Submissions and Approvals

FDA Clears Complete Blood Cell Count Analyzer

Nov. 10, 2017

The FDA has granted premarket clearance and a waiver under the Clinical Laboratory Improvement Amendments of 1988 to Sysmex America for its complete blood cell count test.

Broadened access to the XW-100 automated hematology analyzer for patients at least 2-years-old in additional healthcare settings such as non-traditional laboratories, will allow for faster availability of results, the agency said.

The analyzer provides results from a complete blood count test more quickly than the standard  24-hour delivery.

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