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Assessing the Quality of Immunoassay Systems: 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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Chairholder: Dorothy J. Ball, PhD

Date of Publication: April 20, 2004

Order Code PDF: CLSI ILA23AE
ISBN Number: 1-56238-533-X

Order Code Print: print not available

Edition: First

Pages: 52

CLSI I/LA23 Additional Details

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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 archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid as of September 2016. Because of its value to the laboratory community, it is being retained in CLSI’s library.