Precautions for In Vitro Diagnostic Reagents Labeling
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.
In Vitro Diagnostic ReagentsInstructions for useComponentsCalibratorControlPrinciples of procedurePerformance