Full range C-reactive protein (ultra-sensitive CRP+conventional CRP) detection reagent kit (immunochromatography) - NMPA Registration 渝械注准20202400010
Access comprehensive regulatory information for Full range C-reactive protein (ultra-sensitive CRP+conventional CRP) 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20202400010 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 hypersensitive C-reactive protein and C-reactive protein in human samples (serum, plasma or whole blood) in vitro, and is mainly used clinically as a non-specific inflammatory indicator or auxiliary diagnosis for the identification of cardiovascular disease risk.
用于体外定量检测人体样本（血清、血浆或全血）中超敏C反应蛋白和C反应蛋白的含量，临床上主要作为一种非特异性炎症指标或对心血管疾病风险识别的辅助诊断。
The kit consists of a full-scale C-reactive protein (ultrasensitive CRP+ conventional CRP) detection reagent card, desiccant, aluminum foil bag, and instruction manual. Full-scale C-reactive protein (ultrasensitive CRP+ conventional CRP) detection reagent card: C-reactive protein monoclonal antibody, nitrocellulose membrane, gold standard pad, sample pad, absorbent paper, plastic card.
试剂盒由全量程C反应蛋白（超敏CRP+常规CRP）检测试剂卡、干燥剂、铝箔袋、说明书组成。 全量程C反应蛋白（超敏CRP+常规CRP）检测试剂卡：C反应蛋白单克隆抗体、硝酸纤维素膜、金标垫、样品垫、吸水纸、塑料卡。
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。