FDA clears new, faster CBC test

Editor's Note

The Food and Drug Administration (FDA) on November 6 cleared a new complete blood cell count (CBC) test that can be run in more healthcare settings and offers faster results for patients and providers.

The FDA granted premarket clearance and a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for the new test−XW-100 Automated Hematology Analyzer−to Sysmex America, Inc (Lincolnshire, Illinois).

The U.S. Food and Drug Administration today cleared a complete blood cell count (CBC) test that, based on its categorization, can be run in more health care settings, including physicians' offices, clinics or other types of health care facilities, by a wider range of personnel (e.g. support staff).

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