圣湘生物:四款产品取得医疗器械注册证

Core Viewpoint - The company has received medical device registration certificates from the National Medical Products Administration for four products, indicating regulatory approval and potential market entry [1] Group 1: Product Details - Two respiratory "small joint inspection" products have high sensitivity, high specificity, and ease of operation, capable of providing results in as fast as 30 minutes [1] - The products target major pathogens responsible for community-acquired pneumonia and pediatric respiratory infections, including Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis [1] - The company has upgraded its EB virus nucleic acid detection kit, enhancing detection sensitivity and supporting various specimen types such as plasma and whole blood [1] - The CYP3A5 gene polymorphism nucleic acid detection kit is designed to guide clinical medication plans for the core anti-rejection drug tacrolimus post-transplant [1]