Gastric proenzyme I and gastric proenzyme II detection reagent kit (immunochromatography) - NMPA Registration 渝械注准20202400012
Access comprehensive regulatory information for Gastric proenzyme I and gastric proenzyme II detection reagent kit (immunochromatography) 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20202400012 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 pepsinogen I and pepsinogen II in human samples (serum, plasma or whole blood) in vitro, and is mainly used clinically to evaluate the function of gastric acid gland cells and fundic mucosal gland lesions.
用于体外定量检测人体样本（血清、血浆或全血）中胃蛋白酶原I和胃蛋白酶原Ⅱ的含量，临床上主要用于评价胃泌酸腺细胞功能及胃底粘腺病变。
The kit is mainly composed of pepsinogen I and pepsinogen II combined detection reagent card. The reagent card is composed of nitrocellulose membrane, gold standard pad, sample pad, absorbent paper and plastic card, among which the gold standard pad has murine anti-human pepsinogen I monoclonal labeled antibody and murine anti-human pepsinogen II monoclonal labeled antibody, sheep anti-murine IgG antibody on the quality control line (C), murine anti-human pepsinogen I monoclonal coated antibody and murine anti-human pepsinogen II monoclonal coated antibody on the detection line (T).
试剂盒主要由胃蛋白酶原I、胃蛋白酶原II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胃蛋白酶原I单克隆标记抗体和鼠抗人胃蛋白酶原II单克隆标记抗体，质控线（C）上有羊抗鼠IgG抗体，检测线（T）上有鼠抗人胃蛋白酶原I单克隆包被抗体和鼠抗人胃蛋白酶原II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。