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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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Publication Details

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

Edition: Third

Pages: 120

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.