近日，迈克生物股份有限公司宣布其自主研发的交叉配血质控品成功获得国家药品监督管理局（NMPA）颁发的医疗器械注册证。这一认证标志着该产品在临床输血安全领域迈出了关键一步，也体现了迈克生物在体外诊断（IVD）质控产品领域的技术实力与合规能力。交叉配血是输血前的重要检测步骤，用于确保供血者与受血者血液相容，避免发生溶血等严重输血反应。高质量的质控品对于保障交叉配血检测结果的准确性至关重要。迈克生物此次获批的交叉配血质控品可有效模拟真实临床样本，覆盖多种血型系统和抗体类型，适用于主流交叉配血平台，帮助实验室实现标准化、规范化质控管理。该产品的上市不仅填补了国内相关领域的部分空白，也为医疗机构提供了更可靠、稳定的国产化选择。未来，迈克生物将继续聚焦临床需求，推动更多高质量IVD产品的研发与注册，助力提升我国输血医学的整体水平。
Recently, Maccura Biotechnology Co., Ltd. announced that its self-developed crossmatch quality control product has successfully obtained a medical device registration certificate from China’s National Medical Products Administration (NMPA). This certification marks a significant milestone in clinical transfusion safety and underscores Maccura’s technical expertise and regulatory compliance capabilities in the field of in vitro diagnostic (IVD) quality control products.Crossmatching is a critical pre-transfusion test to ensure compatibility between donor and recipient blood, thereby preventing severe hemolytic transfusion reactions. High-quality control materials are essential for ensuring the accuracy of crossmatch test results. Maccura’s newly approved crossmatch quality control product effectively mimics real clinical samples, covering multiple blood group systems and antibody types. It is compatible with mainstream crossmatch platforms, enabling laboratories to achieve standardized and consistent quality control practices.The launch of this product not only addresses a gap in the domestic market but also provides healthcare institutions with a reliable, high-performance domestic alternative. Moving forward, Maccura will continue to focus on clinical needs and accelerate the development and registration of more high-quality IVD products, contributing to the advancement of transfusion medicine in China.
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