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Evaluation of Stability of In Vitro Diagnostic Reagents, 1st Edition

This document provides guidance for establishing shelf-life and in-use stability claims for in vitro diagnostic reagents such as reagent kits, calibrators, and control products.

This document is available in electronic format only.

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Publication Details

Chairholder: James F. Pierson-Perry

Date of Publication: September 23, 2009

ISBN Number: 1-56238-706-5

Order Code PDF: EP25AE

Order Code Print: print not available

Edition: First

Pages: 52

EP25 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.