Full-length C-reactive protein assay kit (latex-enhanced immunoturbidimetry method) - NMPA Registration 湘械注准20222400072
Access comprehensive regulatory information for Full-length C-reactive protein assay kit (latex-enhanced immunoturbidimetry 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20222400072 and owned by Hunan Huaxi Pharmaceutical Co., Ltd.. The device was approved on January 18, 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 determine the content of C-reactive protein (CRP) 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(CRP)的含量,作辅助诊断用。
R1: phosphate buffer, sodium chloride, macrogol 6000, sodium azide; R2: phosphate buffer, anti-human CRP-IgG sensitized latex particle suspension, sodium azide; Calibrator: phosphate buffer, C-reactive protein, sodium azide; Controls: phosphate buffer, C-reactive protein, sodium azide.
R1:磷酸盐缓冲液、氯化钠、聚乙二醇6000、叠氮钠;R2:磷酸盐缓冲液、抗人 CRP-IgG 致敏的乳胶颗粒悬液、叠氮钠;校准品:磷酸盐缓冲液、C-反应蛋白、叠氮钠;质控品:磷酸盐缓冲液 、C-反应蛋白、叠氮钠。
Store at 2~8°C, valid for 1 year.
2～8℃储存，有效期为1年。