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Author Spotlight: Development of Simplified CRISPR-Based Tests for Rapid Detection of Infectious Diseases
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[Discussion on Regulatory Risk of in Vitro Diagnostic Reagents in Use]
Zhe Li1, Haixin Jiang1, Jingke Wang1
1General Enforcement Team of Shanghai Food and Drug Administration, Shanghai, 200233.
Abstract:
According to the information of the supervision and inspection of in vitro diagnostic reagents for clinical use, this article analyzed the compliance issues and discussed the methods to solve the problems, to urge medical institutions to reduce the regulatory risk of in vitro diagnostic reagents in use.
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