Myocardial calcium protein I, creatine kinase isoenzyme, myoglobin combined test kit (immunochromatography method) - NMPA Registration 渝械注准20202400020
Access comprehensive regulatory information for Myocardial calcium protein I, creatine kinase isoenzyme, myoglobin combined test kit (immunochromatography method) 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20202400020 and owned by Chongqing Zhongyuan BIO-TECHNOLOGY Co., Ltd.. The device was approved on December 13, 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 troponin I (cTnI), creatine kinase isoenzyme (CK-MB), myoglobin (Myo) in human samples (serum, plasma or whole blood) in vitro, and is mainly used clinically for the auxiliary diagnosis of myocardial infarction.
用于体外定量检测人体样本（血清、血浆或全血）中肌钙蛋白I（cTnI）、肌酸激酶同工酶（CK-MB）、肌红蛋白（Myo）的含量，临床上主要用于心肌梗死的辅助诊断。
The kit is mainly composed of troponin I (cTnI), creatine kinase isoenzyme (CK-MB), myoglobin (Myo) combined detection reagent card. The reagent card is composed of nitrocellulose membrane, gold pad, sample pad, absorbent paper and plastic card, in which the gold pad has murine anti-human troponin I monoclonal labeled antibody, murine anti-human creatine kinase isoenzyme monoclonal labeled antibody and murine anti-human myoglobin monoclonal labeled antibody, sheep anti-mouse IgG antibody on the quality control line (C), murine anti-human troponin I monoclonal coated antibody, murine anti-human creatine kinase isoenzyme monoclonal coated antibody and murine anti-human myoglobin monoclonal coated antibody on the detection line (T).
试剂盒主要由肌钙蛋白I（cTnI）、肌酸激酶同工酶（CK-MB）、肌红蛋白（Myo）联合检测试剂卡组成。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肌钙蛋白I单克隆标记抗体、鼠抗人肌酸激酶同工酶单克隆标记抗体和鼠抗人肌红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）上有鼠抗人肌钙蛋白I单克隆包被抗体、鼠抗人肌酸激酶同工酶单克隆包被抗体和鼠抗人肌红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。