An Introduction for the Current Regulatory Status and Technical Evaluation Focus of Tumor Marker Quantitative Detection Reagents
Tumor marker quantitative detection reagents are one type of reagents that are currently widely used in clinical practice.There are many types of such reagents,and the amount of marketed,declared and new products at the development stage is also extremely abundant.The aim of this paper is to systematically elaborate the current status of the supervision of such type of products.Furthermore,based on current relevant regulations and applicable technical documents,combined with the relevant review experience,the common review concerns in the registration and application of this type of reagent are introduced in detail to provide references for relevant personnel.
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