Lipoprotein-Associated Phospholipase A2 (Lp-PLA2) Detection Kit (Latex-Enhanced Immuno Turbidimetric Method) - NMPA Registration 川械注准20232400408
Access comprehensive regulatory information for Lipoprotein-Associated Phospholipase A2 (Lp-PLA2) Detection Kit (Latex-Enhanced Immuno Turbidimetric 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20232400408 and owned by Sichuan Xincheng Biological Co., Ltd.. The device was approved on November 28, 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.
The concentration of lipoprotein-associated phospholipase A2 in human serum and human plasma samples was quantitatively determined in vitro.
体外定量测定人血清、人血浆样本中脂蛋白相关磷脂酶A2的浓度。
See attached page II
见附页二
The validity period of the reagent is 18 months when stored at 2°C~8°C and protected from light, and it can be stable for 14 days when the bottle is opened and stored at 2°C~8°C. Calibrators and quality controls can be stored in the dark at 2°C~8°C after opening, and can be stable for 21 days.
试剂2℃～8℃密闭避光贮存有效期为18个月，开瓶上机2℃～8℃避光贮存可稳定14天。校准品、质控品开瓶后2℃～8℃避光贮存可稳定21天。