Lipoprotein-Associated Phospholipase A2 Determination Reagent Kit (Latex Immunoturbidimetry Method) - NMPA Registration 吉械注准20242400608
Access comprehensive regulatory information for Lipoprotein-Associated Phospholipase A2 Determination Reagent Kit (Latex 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 吉械注准20242400608 and owned by Dirui Industrial Co., Ltd.. The device was approved on September 12, 2024.
This page provides complete registration details including registrant information, province location (Jilin), 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 for in vitro quantitative detection of lipoprotein-associated phospholipase A2 content in human serum and plasma samples.
用于体外定量检测人血清、血浆样本中脂蛋白相关磷脂酶A2的含量。
Kit composition Main components Concentration Reagent 1 (R1) Tris(hydroxymethyl)aminomethane buffer ≥10mmol/L Reagent 2(R2) Anti-human lipoprotein-associated phospholipase A2 sensitized latex granules ≥0.05% Calibrator solution containing lipoprotein-associated phospholipase A2 See Label Controls solution containing lipoprotein-associated phospholipase A2 see label
试剂盒组成 主要组成成分 浓度 试剂1（R1） 三（羟甲基）氨基甲烷缓冲液 ≥10mmol/L 试剂2（R2） 抗人脂蛋白相关磷脂酶A2致敏乳胶颗粒 ≥0.05% 校准品 含有脂蛋白相关磷脂酶A2的溶液 见标签 质控品 含有脂蛋白相关磷脂酶A2的溶液 见标签