亚辉龙(688575.SH)：人绒毛膜促性腺激素及β亚单位测定试剂盒取得医疗器械注册证

Core Insights - The company, Aihuilong (688575.SH), has received a medical device registration certificate from the National Medical Products Administration for its Human Chorionic Gonadotropin (HCG) and β Subunit Assay Kit (Chemiluminescence Method) [1][3] - The product is intended for in vitro quantitative measurement of HCG and its β subunit in human serum and/or plasma, primarily for dynamic monitoring of malignant tumor patients to assist in assessing disease progression or treatment efficacy [1][2] Product Details - HCG is a glycoprotein hormone secreted by trophoblast cells of the placenta, consisting of an α subunit and a β subunit, with a molecular weight of 37 kDa [2] - The hormone exists in various forms in the blood, including intact HCG, free α subunit, and free β subunit, and is used clinically for diagnosing ectopic pregnancy and early pregnancy [2] - Abnormal elevation of HCG is often associated with malignant tumors such as testicular cancer and bladder cancer, with β-HCG being a valuable marker for monitoring trophoblastic diseases [2] Company Developments - The company has obtained a total of 172 domestic medical device registration certificates for chemiluminescence reagents, contributing to a total of 249 registrations [3] - The recent registration enhances the company's automated chemiluminescence product line and expands its testing portfolio in reproductive hormones and tumor markers [3]