Cystatin C determination reagent kit (latex-enhanced turbidimetry) - NMPA Registration 湘械注准20222400033
Access comprehensive regulatory information for Cystatin C determination reagent kit (latex-enhanced turbidimetry) 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20222400033 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 cystatin C 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胱抑素 C 的含量,作辅助诊断用。
Reagent 1: phosphate glycine buffer; Reagent 2: Allergenic latex particle suspension against Cys-C-IgG.
试剂1：磷酸盐甘氨酸缓冲液；试剂2：抗 Cys-C-IgG的致敏乳胶颗粒悬液。
Store at 2~8°C in the dark for 1 year.
2～8˚C 避光保存1年。