Ferritin determination reagent kit (latex enhanced immunoturbidimetric method) - NMPA Registration 湘械注准20222400073
Access comprehensive regulatory information for Ferritin 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20222400073 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 determine the content of ferritin Ferrtin in human serum in vitro, for medical institutions to assist diagnosis, not for tumor screening.
供医疗机构用于体外定量测定人血清中的铁蛋白 Ferrtin 的含量,供医疗机构作辅助诊断用,不做肿瘤筛查用。
R1: phosphate buffer, sodium chloride, macrogol 6000, sodium azide; R2: phosphate buffer, murine anti-human ferritin monoclonal antibody sensitized latex particle suspension, sodium azide; Calibrator: phosphate buffer, ferritin, sodium azide; Controls: phosphate buffer, ferritin, 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、鼠抗人铁蛋白单克隆抗体致敏的乳胶颗粒悬液、叠氮钠;校准品: 磷酸盐缓冲液、铁蛋白、叠氮钠;质控品:磷酸盐缓冲液、铁蛋白、叠氮钠。
Store at 2~8°C, valid for 1 year.
2～8℃储存，有效期为1年。