广州达安基因股份有限公司关于取得一个医疗器械注册证的提示性公告

Core Points - The company has obtained a medical device registration certificate for a Chikungunya virus nucleic acid detection kit, which is intended for in vitro qualitative detection of the virus in suspected cases [1][2] - The registration certificate is valid until September 24, 2030, and the product is currently in the market development stage, indicating potential uncertainty in market demand [2][3] Group 1 - The medical device name is Chikungunya Virus Nucleic Acid Detection Kit (Fluorescent PCR Method), with registration number 20253401955 [1] - The kit is designed for detecting Chikungunya virus nucleic acid in serum samples from suspected cases and should be used in accordance with relevant guidelines [1][2] - The company emphasizes that the test results are for clinical reference only and should not be the sole basis for clinical diagnosis [1] Group 2 - The acquisition of this registration certificate enriches the company's product portfolio and expands its application areas [2] - The company advises investors to be aware of investment risks due to the current uncertainty in market demand for the new product [2]