Medical device science popularization and education is a long-term and important task

With the growing public demand for health and disease prevention services, there is a rising awareness of the quality and safety of diagnostic reagents used in healthcare.

What are in-vitro diagnostic reagents?

According to China's "Registration and Administration Measures for In Vitro Diagnostic Reagents" issued in 2014, in vitro diagnostic reagents (IVDs) managed as medical devices are reagents, reagent kits, calibrators, quality control products, etc., used for in vitro testing of human samples in the process of disease prediction, prevention, diagnosis, treatment monitoring, prognosis investigation, and health status assessment.

How to name an in-vitro diagnostic reagent product

In China, there are clear naming requirements for in-vitro diagnostic reagents; arbitrary naming is not permitted. The naming of in-vitro diagnostic reagents should follow the following guidelines

What are the main forms of in-vitro diagnostic reagent test results?

Currently, in-vitro diagnostic reagents are used for testing and analysis, and the results are mainly presented in three forms

What are the similarities and differences between in-vitro diagnostic reagents and traditional testing methods?

In vitro diagnostic reagents have many similarities and differences compared to traditional testing methods. The following comparison from Zhejiang Tuochuang Medical will cover aspects such as principles, advantages, and disadvantages.

Do you understand the principles and techniques of using in-vitro diagnostic reagents?

In vitro diagnostic reagents are an indispensable part of modern medical testing and can be used to detect various disease markers, such as blood glucose, blood lipids, liver function, kidney function, cardiac enzymes, and cancer markers.