关键词: font-size:medium, ">体外诊断试剂；说明书；主要组成成分；校准品；质控品；检验方法；性能指标

Abstract: The instructions for use of in vitro diagnostic reagents as an essential attachment to the product registration certificate not only guide users on how to properly use the product， but also serve to showcase the product′s performance. They are also a key basis and means of regulatory oversight. Currently， there are some common problems in the preparation of instructions for use that require attention from applicants for product registration. Ensuring the scientific rigor and standardized uniformity of product instructions for use is crucial for guiding users to use the product accurately and without error.

Key words: font-size:medium, "> , In Vitro Diagnostic Reagents； Instructions for use；Components； Calibrator； Control； Principles of procedure； Performance