EP25
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.