Pepsinogen II assay kit (chemiluminescence immunoassay) - NMPA Registration 苏械注准20242400335
Access comprehensive regulatory information for Pepsinogen II assay kit (chemiluminescence 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 苏械注准20242400335 and owned by Suzhou Hokapi Biomedical Engineering Co., Ltd.. The device was approved on March 08, 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 the quantitative determination of pepin II. concentration in human serum in vitro, and is clinically used to monitor the concentration level of PGII. and the ratio of PGI./II. for the treatment and monitoring of gastric cancer
用于体外定量测定人血清中胃蛋白酶原 Ⅱ 的浓度，临床上用于监测 PGⅡ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 pepsinogen II.specific monoclonal antibody (mouse), 0.1M pH 7.0 phosphate buffer, 0.1% biological preservative; Reagent 2: Pepsinogen II.specific monoclonal antibody containing acridine ester labeling (mouse), 0.1M phosphate buffer pH 7.0, 0.1% biological preservative; Magnetic particles: containing streptavidin-coated particles, treated with antiseptic; Calibrator 1, Calibrator 2, Calibrator 3: Contains human pepsinogen II., 0.1M pH 7.0 phosphate buffer, calf serum albumin, 0.1% biological preservative. (Calibrator traceability to in-house calibrator)
试剂1：内含生物素化胃蛋白酶原Ⅱ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：内含吖啶酯标记的胃蛋白酶原Ⅱ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Ⅱ，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）
Store at 2°C~8°C, valid for 18 months; The opened reagent can be stored at 2°C~8°C for 60 days; It can be placed on the analyzer (reagent chamber temperature 2°C~8°C) and can be stable for 7 days.
2℃～8℃保存，有效期18个月；开封的试剂2℃～8℃保存可稳定60天；置于分析仪（试剂仓温度2℃～8℃）上，可稳定7天。