Chylomicron E determination reagent kit (latex-enhanced immune turbidimetry method) - NMPA Registration 川械注准20232400263
Access comprehensive regulatory information for Chylomicron E determination reagent kit (latex-enhanced immune turbidimetry 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 川械注准20232400263 and owned by Sichuan Xincheng Biological Co., Ltd.. The device was approved on August 17, 2023.
This page provides complete registration details including registrant information, province location (Sichuan), 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.
In vitro quantitative determination of the concentration of apolipoprotein E in human serum and human plasma samples.
体外定量测定人血清、人血浆样本中载脂蛋白E的浓度。
See attached page II
见附页二
The reagent is stored in 2 °C ~ 8 °C closed and protected from light for 18 months, and the storage at 2 °C ~ 8 °C can be stable for 14 days after opening. After the reconstitution of calibrators and quality control products, they can be stable for 2 days when stored at 2 °C ~ 8 °C in the dark, and can be stable for one week at -20 °C, and cannot be repeatedly frozen and thawed.
试剂2℃～8℃密闭避光贮存有效期为18个月，开瓶后2℃～8℃避光贮存可稳定14天。校准品、质控品复溶后2℃～8℃避光贮存可稳定2天，-20℃保存可稳定一周，不可反复冻融。