Gastric protease I detection reagent kit (chemiluminescence immunoassay method) - NMPA Registration 苏械注准20242400365
Access comprehensive regulatory information for Gastric protease I detection reagent kit (chemiluminescence immunoassay 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 苏械注准20242400365 and owned by Suzhou Hokapi Biomedical Engineering Co., Ltd.. The device was approved on March 13, 2024.
This page provides complete registration details including registrant information, province location (Jiangsu), 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 in vitro quantitative detection of the concentration of pepsinogen I in human serum. Clinically, it is used to monitor the concentration level of PGI. and the ratio of PGI./II. can be used for the treatment of gastric cancer.
用于体外定量检测人血清中胃蛋白酶原Ⅰ的浓度。临床上用于监测PGⅠ的浓度水平及PGⅠ/Ⅱ的比值可用于胃癌的治疗监测。
Reagent 1: Contains biotinylated antipepsinogen I.-specific monoclonal antibody (mouse), 0.1M pH 7.0 phosphate buffer, 0.1% biological preservative; Reagent 2: Contains acridine ester-labeled anti-pepsinogen I.specific monoclonal antibody (mouse), 0.1 M pH 7.0 phosphate buffer, 0.1% biological preservative; Magnetic particles: containing streptavidin-coated particles, treated with antiseptic; Calibrator 1, Calibrator 2, Calibrator 3: Contains human pepsinogen I., 0.1M pH 7.0 phosphate buffer, calf serum albumin, 0.1% biological preservative. (Calibrator traceability to in-house calibrator)
试剂1：内含生物素化抗胃蛋白酶原Ⅰ特异性单克隆抗体（小鼠），0.1M pH值7.0磷酸盐缓冲液，0.1%生物防腐剂；试剂2：内含吖啶酯标记的抗胃蛋白酶原Ⅰ特异性单克隆抗体（小鼠），0.1M pH值7.0磷酸盐缓冲液，0.1%生物防腐剂；磁颗粒：内含链霉亲和素包被的微粒，经防腐处理；校准品1、校准品2、校准品3：内含人源性的胃蛋白酶原Ⅰ，0.1M pH值7.0磷酸盐缓冲液，小牛血清白蛋白，0.1%生物防腐剂。（校准品溯源至企业内部校准品）
2°C~8°C storage, valid for 18 months; The opened reagent can be stable for 60 days when stored at 2 °C ~ 8 °C.
2℃～8℃保存，有效期18个月；开封的试剂2℃～8℃保存可稳定60天。