Core Viewpoint - The announcement indicates that the wholly-owned subsidiary of the company, Hunan Yahui Long Biotechnology Co., Ltd., has received medical device registration certificates for two antibody testing kits, enhancing its product line in the field of autoimmune disease detection [1] Group 1 - The registered products are the anti-phosphatidylserine/prothrombin IgM antibody test kit and the anti-phosphatidylserine/prothrombin IgG antibody test kit, both utilizing chemiluminescence methods [1] - The registration numbers for the products are 湘械注准20252400986 and 湘械注准20252400987, with a validity period until December 11, 2030 [1] - The acquisition of these registration certificates will help to further enrich the company's fully automated chemiluminescence product line [1]

南财智讯12月15日电，亚辉龙公告，公司全资子公司湖南亚辉龙生物科技有限公司收到湖南省药品监督 管理局的医疗器械注册证，涉及两款产品，分别为抗磷脂酰丝氨酸/凝血酶原IgM抗体测定试剂盒（化学 发光法）和抗磷脂酰丝氨酸/凝血酶原IgG抗体测定试剂盒（化学发光法）。上述产品预期用途为体外定 量测定人血清和（或）血浆中相关抗体含量，临床上主要用于抗磷脂抗体综合征（APS）的辅助诊断。 本次注册证的取得有利于丰富公司全自动化学发光产品线，完善自身免疫性疾病领域检测套餐。上述注 册证的取得仅代表相关产品获得国内市场准入资格，产品上市后的具体销售情况可能受到市场环境改变 等因素影响，公司尚无法预测其对未来业绩的影响。 ...