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I/LA21

Clinical Evaluation of Immunoassays, 2nd Edition

This document addresses the need for clinical evaluation of new immunoassays and new applications of existing assays, as well as multiple assay formats and their uses. As a guide to designing and executing a clinical evaluation, this document will aid developers of "in-house" assays for institutional use, developers of assays used for monitoring pharmacologic effects of new drugs or biologics, and clinical and regulatory personnel responsible for commercializing products.  

This document is available in electronic format only.

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Publication Details

Chairholder: Marilyn M. Lightfoote, MD, PhD

Date of Publication: August 29, 2008

ISBN Number: 1-56238-674-3

Order Code PDF: ILA21A2E

Order Code Print: print not available

Edition: Second

Pages: 68

I/LA21 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.

This document is no longer being reviewed as part of our consensus process. However, because of its usefulness to a limited segment of the healthcare community, we are continuing to make the document available for its informational content.