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Full Description

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. 

 

Document History

  1. CLSI EP25-Ed2

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    Evaluation of Stability of In Vitro Medical Laboratory Test Reagents, 2nd Edition, EP25Ed2E

    • Most Recent
  2. CLSI EP25-A


    Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline, EP25A

    • Historical Version
  3. CLSI EP25-P


    Evaluation of Stability of In Vitro Diagnostic Method Products; Proposed Guideline, EP25PE

    • Historical Version