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FDA clears CBC test for CLIA waived test

The U.S. Food and Drug Administration 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). This broadened test access will allow for faster availability of results. An Automated Hematology Analyzer was granted a waiver under CLIA.