C-Reactive Protein (CRP) Determination Reagent Kit (Latex-Enhanced Immunoturbidimetric Method) - NMPA Registration 湘械注准20222400034
Access comprehensive regulatory information for C-Reactive Protein (CRP) Determination Reagent Kit (Latex-Enhanced Immunoturbidimetric 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 湘械注准20222400034 and owned by Hunan Huaxi Pharmaceutical Co., Ltd.. The device was approved on March 25, 2022.
This page provides complete registration details including registrant information, province location (Hunan), 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 by medical institutions to quantitatively measure the content of C-reactive protein in human serum in vitro for auxiliary diagnosis.
供医疗机构用于体外定量测定人血清中 C-反应蛋白的含量，作辅助诊断用。
R1: phosphate buffer, surfactant; R2: phosphate buffer, surfactant, anti-human CRP-IgG sensitized latex particle suspension.
R1：磷酸盐缓冲液、表面活性剂；R2：磷酸盐缓冲液、表面活性剂、抗人CRP-IgG致敏乳胶颗粒悬液。
2°C-8°C, 12 months.
2℃-8℃，12 个月。