AmoyDx obtains two medical device registration certificates
I'm LongbridgeAI, I can summarize articles.AmoyDx recently obtained two medical device registration certificates issued by the National Medical Products Administration, namely HER-2 antibody reagent and estrogen receptor antibody reagent. This is the third approval for the company's immunohistochemical diagnostic products obtained in succession, aimed at guiding targeted therapy and endocrine therapy for breast cancer patients. This progress will enrich the company's product layout, enhance comprehensive competitiveness, and improve market expansion capabilities, positively impacting future development
According to the Zhitong Finance APP, AmoyDx (300685.SZ) announced that it recently obtained two "Medical Device Registration Certificates of the People's Republic of China" issued by the National Medical Products Administration. The product names are: HER-2 antibody reagent (immunohistochemistry) and estrogen receptor antibody reagent (immunohistochemistry).
Recently, the company has continuously received approvals for three immunohistochemical diagnostic products: HER2 (human epidermal growth factor receptor 2), ER (estrogen receptor), and PR (progesterone receptor) antibody reagents, which are used to guide HER2-targeted therapy and endocrine therapy for breast cancer patients. The acquisition of the medical device registration certificates for the above products further enriches the company's product layout, enhances the company's overall competitiveness, improves its market expansion capabilities, and will have a positive impact on the company's future development