CLSI-EP25-A(体外诊断试剂稳定性评价).pdfVIP

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CLSI-EP25-A(体外诊断试剂稳定性评价).pdf

September2009

EP25-A

EvaluationofStabilityofInVitroDiagnostic

Reagents;ApprovedGuidelineE

L

P

M

A

Thisdocumentprovidesguidanceforestablishingshelf-life

S

andin-usestabilityclaimsforinvitrodiagnosticreagents

suchasreagentkits,calibrators,andcontrolproducts.

AguidelineforglobalapplicationdevelopedthroughtheClinicalandLaboratoryStandardsIn

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