Heart-Type Fatty Acid Binding Protein Detection Reagent Kit (Immunoassay) - NMPA Registration 渝械注准20202400019
Access comprehensive regulatory information for Heart-Type Fatty Acid Binding Protein Detection Reagent Kit (Immunoassay) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 渝械注准20202400019 and owned by Chongqing Zhongyuan BIO-TECHNOLOGY Co., Ltd.. The device was approved on October 15, 2021.
This page provides complete registration details including registrant information, province location (Chongqing), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.
It is used for the quantitative detection of the content of central fatty acid-binding protein in human samples (serum, plasma or whole blood) in vitro, and is mainly used clinically to assist the diagnosis of acute myocardial infarction.
用于体外定量检测人体样本（血清、血浆或全血）中心型脂肪酸结合蛋白的含量，临床上主要用于急性心肌梗死辅助诊断。
The kit consists mainly of cardioid fatty acid-binding protein detection cards. The reagent card is composed of nitrocellulose membrane, gold pad, sample pad, absorbent paper and plastic card, among which the gold pad has murine anti-human cardiotype fatty acid binding protein monoclonal labeled antibody, sheep anti-mouse IgG antibody on the quality control line (C), and murine anti-human cardiotype fatty acid-binding protein monoclonal coated antibody on the detection line (T).
试剂盒主要由心型脂肪酸结合蛋白检测试剂卡组成。该试剂卡由硝酸纤维素膜、金标垫、样品垫、吸水纸和塑料卡组成，其中金标垫上有鼠抗人心型脂肪酸结合蛋白单克隆标记抗体，质控线（C）上有羊抗鼠IgG抗体，检测线（T）上有鼠抗人心型脂肪酸结合蛋白单克隆包被抗体。
Under the condition of aluminum foil bag sealing, 4~30 °C dry, dark environment storage, not frozen. The product is valid for 18 months.
在铝箔袋密封的条件下，4~30℃干燥、避光环境储存，不得冻存。产品有效期为18个月。