Core Viewpoint - The company has received a medical device registration certificate from the National Medical Products Administration for its Hepatitis B core antibody detection kit, indicating a significant regulatory approval milestone [1] Group 1 - The product is named Hepatitis B Virus Core Antibody Detection Kit (Chemiluminescence Method) [1] - The registration number is National Medical Device Registration No. 20253401061, with a validity period until May 28, 2030 [1] - The product is classified as a Class III medical device, which is typically associated with higher risk and regulatory scrutiny [1] Group 2 - The kit is designed for the in vitro quantitative measurement of Hepatitis B virus core antibody (Anti-HBc) in human serum or plasma [1] - It serves as an auxiliary diagnostic tool for Hepatitis B virus infection [1]