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Radioimmunoassays and Enzyme, Fluorescence, and Luminescence Immunoassays, 1st Edition

This guideline addresses components for harmonizing and assessing the quality of immunoassay systems for several commonly used dose-response indicator categories, e.g., radioisotopes, enzymes, fluorescence, luminescence, reagents, and experimental components criteria essential to characterizing an immunoassay.  

This document is available in electronic format only.

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Publication Details

Chairholder: Dorothy J. Ball, PhD

Date of Publication: April 20, 2004

ISBN Number: 1-56238-533-X

Order Code PDF: ILA23AE

Order Code Print: print not available

Edition: First

Pages: 52

I/LA23 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.