Lipoprotein-Associated Phospholipase A2 (Lp-PLA2) Detection Kit (Latex-Enhanced Immuno Turbidimetric Method) - NMPA Registration 鲁械注准20242401055
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 鲁械注准20242401055 and owned by Qingdao Hightop Biotech Co., Ltd.. The device was approved on December 02, 2024.
This page provides complete registration details including registrant information, province location (Shandong), 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.
用于体外定量测定人血清中脂蛋白相关磷脂酶A2(Lp-PLA2)的含量.
用于体外定量测定人血清中脂蛋白相关磷脂酶A2（Lp-PLA2）的含量。
试剂R1:三羟甲基氨基甲烷(6.4g/L)、氯化钠(8.0g/L)、乙二胺四乙酸二钠(0.83g/L)、牛血清白蛋白(2.70g/L)、Proclin 300(0.4ml/L); 试剂R2:聚苯乙烯胶乳微球(15g/L)、脂蛋白相关磷脂酶A2抗体1(40mg/L)、脂蛋白相关磷脂酶A2抗体2(40mg/L)、Proclin 300(0.3ml/L)、氯化钠(1.80g/L). 校准品(选配):脂蛋白相关磷脂酶A2抗原,批特异,定值见瓶签. 质控品(选配):脂蛋白相关磷脂酶A2抗原,批特异,靶值范围见瓶签.
试剂R1：三羟甲基氨基甲烷（6.4g/L）、氯化钠（8.0g/L）、乙二胺四乙酸二钠（0.83g/L）、牛血清白蛋白（2.70g/L）、Proclin 300（0.4ml/L）； 试剂R2：聚苯乙烯胶乳微球（15g/L）、脂蛋白相关磷脂酶A2抗体1（40mg/L）、脂蛋白相关磷脂酶A2抗体2（40mg/L）、Proclin 300（0.3ml/L）、氯化钠（1.80g/L）。 校准品（选配）：脂蛋白相关磷脂酶A2抗原，批特异，定值见瓶签。 质控品（选配）：脂蛋白相关磷脂酶A2抗原，批特异，靶值范围见瓶签。
2 °C ~ 8 °C storage, valid for 12 months.
2℃～8℃保存，有效期12个月。