Prostate acid phosphatase detection kit (chemiluminescent immunoassay) - NMPA Registration 苏械注准20242400402
Access comprehensive regulatory information for Prostate acid phosphatase detection kit (chemiluminescent 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20242400402 and owned by Suzhou Hokapi Biomedical Engineering Co., Ltd.. The device was approved on March 25, 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 prostate acid phosphatase in human serum, and is clinically used to monitor the occurrence of bone metastasis in prostate cancer.
用于体外定量检测人血清中前列腺酸性磷酸酶的浓度，临床上用于监测前列腺癌发生骨转移的情况。
Reagent 1: Contains biotinylated anti-prostate acid phosphatase-specific monoclonal antibody (mouse), 0.05M MES buffer pH 6.0, 0.1% biological preservative; Reagent 2: Monoclonal antibody containing acridine ester-labeled anti-prostate acid phosphatase-specific antibody (mouse), 0.05M MES buffer pH 6.0, 0.1% biological preservative; Magnetic particles: containing streptavidin-coated particles, treated with antiseptic; Calibrator 1, Calibrator 2, Calibrator 3: Contains human prostate acid phosphatase, 0.1M pH 7.0 phosphate buffer, calf serum albumin, 0.1% biological preservative. (Calibrator traceability to in-house calibrator)
试剂1：内含生物素化抗前列腺酸性磷酸酶特异性单克隆抗体（小鼠），0.05M pH6.0的MES缓冲液，0.1%生物防腐剂；试剂2：内含吖啶酯标记的抗前列腺酸性磷酸酶特异性单克隆抗体（小鼠），0.05M pH6.0的MES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：内含人源性的前列腺酸性磷酸酶，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.
2℃～8℃保存，有效期18个月。