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CLSI EP15-A2

User Verification of Performance for Precision and Trueness; Approved Guideline - Second Edition

This document describes the demonstration of method precision and trueness for clinical laboratory quantitative methods utilizing a protocol designed to be completed within five working days or less.The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement

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Clinical And Laboratory Standards Institute [CLSI]


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