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CLSI MM19-A

Establishing Molecular Testing in Clinical Laboratory Environments; Approved Guideline

This guideline provides comprehensive guidance for planning and implementation of molecular diagnostic testing, including strategic planning, regulatory requirements, implementation, quality management, and special considerations for the subspecialties of molecular genetics, infectious diseases, oncology, and pharmacogenetics. molecular regulatory requirements, strategic planning, unidirectional workflow.


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Clinical And Laboratory Standards Institute [clsi]


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