铁蛋白测定试剂盒(胶乳免疫比浊法)

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科华生物:获得铁蛋白测定试剂盒医疗器械注册证
Zheng Quan Shi Bao Wang· 2025-09-18 08:16
人民财讯9月18日电,科华生物(002022)9月18日晚间公告,近日,公司收到上海市药品监督管理局颁 发的医疗器械注册证(体外诊断试剂)。产品名称为铁蛋白测定试剂盒(胶乳免疫比浊法),本试剂盒供医 疗机构用于体外定量测定人血清、血浆样本中铁蛋白(FER)的含量。临床上主要用于铁代谢的相关疾 病,如血色素沉着症和缺铁性贫血的辅助诊断。 ...
科华生物一款产品获得医疗器械注册证
Zhi Tong Cai Jing· 2025-09-18 07:59
Core Viewpoint - Kehua Bio (002022.SZ) has received a medical device registration certificate from the Shanghai Municipal Drug Administration for its Ferritin Assay Kit, which is used for the quantitative measurement of ferritin levels in human serum and plasma samples [1] Group 1 - The Ferritin Assay Kit utilizes the latex immunoturbidimetric method [1] - The kit is intended for use in medical institutions for the auxiliary diagnosis of iron metabolism-related diseases, such as hemochromatosis and iron deficiency anemia [1]