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.
Chairholder: James F. Pierson-Perry
Date of Publication: September 23, 2009
Order Code PDF: EP25AE
ISBN Number: 1-56238-706-5
Order Code Print: print not available
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.