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Evaluation of Stability of In Vitro Medical Laboratory Test Reagents, 2nd 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: Karl De Vore, BA, SSBB

Date of Publication: April 26, 2023

Order Code PDF: EP25Ed2E
ISBN Number: 978-1-68440-179-6

Order Code Print: EP25Ed2
ISBN Number: 978-1-68440-178-9

Edition: Second

Pages: 124

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.