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In Brief: Cholestech

This article was originally published in The Gray Sheet

Executive Summary

Cholestech: Files petition with the Centers for Disease Control and Prevention to reclassify the firm's total cholesterol, HDL cholesterol, triglycerides and glucose tests from the "moderately complex" to "waived" category under provisions of the Clinical Laboratory Improvements Amendments of 1988. CDC recently lifted its moratorium on processing in vitro diagnostic test waiver requests ("The Gray Sheet" Jan. 30, p. 4)...



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