Historical
C28-A2
How to Define and Determine Reference Intervals in the Clinical Laboratory; Approved Guideline - Second Edition
Focuses on health-associated reference values as they relate to quantitative clinical laboratory tests. Included are various requirements for studies to determine reference values for a new analyte or a new analytical method of a previously measured analyte. Also discussed is the transfer of established reference values from one laboratory to another. FDA
CONTENT PROVIDER
Clinical And Laboratory Standards Institute [clsi]
Clinical And Laboratory Standards Institute [clsi]