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

This document provides guidance for establishing shelf-life and in-use stability claims for in vitro diagnostic method products such as reagent kits, calibrators, and control products.

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Clinical And Laboratory Standards Institute [clsi]

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

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EP25-P

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

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