Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen Specificities, 3rd Edition
This report provides guidance for the design, analytical performance, standardization, quality assurance, and clinical application of laboratory assays used in the measurement of human immunoglobulin E antibodies of defined allergen specificity.
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Chairholder: Robert G. Hamilton, PhD, D.ABMLI and Per N. J. Matsson, PhD
Date of Publication: October 1, 2016
ISBN Number: 1-56238-948-3
Order Code PDF: ILA20Ed3E
Order Code Print: ILA20Ed3
I/LA20 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.