C-反应蛋白测定试剂盒（免疫散射比浊法） - NMPA Registration 川械注准20252400002
Access comprehensive regulatory information for C-反应蛋白测定试剂盒（免疫散射比浊法） in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 川械注准20252400002 and owned by Maccura Biotechnology Co., Ltd.. The device was approved on January 08, 2025.
This page provides complete registration details including registrant information, province location (Sichuan), 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.
This product is used for the quantitative determination of the content of C-reactive protein in human whole blood samples in vitro.
本品用于体外定量测定人体全血样本中C-反应蛋白的含量。
试剂盒包含试剂（R）：兔抗人C-反应蛋白多克隆抗体1（0.04～0.08g/L）、兔抗人C-反应蛋白多克隆抗体2（0.02～0.07g/L）、胶乳（0.1%）；校准品：C-反应蛋白；质控品：C-反应蛋白。（具体内容详见产品说明书）
本品于2℃～8℃密闭避光保存，严禁冷冻，有效期为8个月。