CLSI EP25

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

This guideline provides recommendations for establishing and verifying shelf-life and in-use stability claims for in vitro diagnostic medical laboratory test reagents such as reagent kits, calibrators, and control products.

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Chairholder: James F. Pierson-Perry

Date of Publication: September 23, 2009

Order Code PDF: CLSI EP25AE
ISBN Number: 1-56238-706-5

Order Code Print: print not available

Edition: First

Pages: 52

CLSI EP25 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.

CLSI EP25 Abstract

EP25-A | 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. Chairholder: James F. Pierson-Perry Organization: Siemens Healthcare Diagnostics Date of Publication: 09/23/2009 ISBN Number: 1-56238-706-5 Edition: First Edition Pages: 52 Preview Sample Pages Nonmember Price: $180.00 Membership discount will be applied at checkout. This document is available in electronic format only.