Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures, 2nd Edition
This document provides guidance for evaluation and documentation of the detection capability of clinical laboratory measurement procedures (ie, limits of blank, detection, and quantitation), for verification of manufacturers’ detection capability claims, and for the proper use and interpretation of different detection capability estimates.
Members: $54.00 → $153.00Nonmembers: $180.00
Chairholder: James F. Pierson-Perry
Date of Publication: June 18, 2012
ISBN Number: 1-56238-795-2
Order Code PDF: EP17A2E
Order Code Print: EP17A2
EP17 Additional Details
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.