Lipoprotein-associated phospholipase A2 assay kit (enzymatic) - NMPA Registration 鲁械注准20242400885
Access comprehensive regulatory information for Lipoprotein-associated phospholipase A2 assay kit (enzymatic) 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20242400885 and owned by Qingdao Hightop Biotech Co., Ltd.. The device was approved on September 23, 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.
For the in vitro quantitative determination of the activity of lipoprotein-associated phospholipase A2 (Lp-PLA2) in human serum.
用于体外定量测定人血清中脂蛋白相关磷脂酶A2（Lp-PLA2）的活性。
试剂 R1:4-羟乙基哌嗪乙磺酸(HEPES)(11.92g/L)、氯化钠(8.10g/L)、乙二胺四乙酸二钠(0.75g/L)、Proclin 300(1ml/L); 试剂 R2:一水柠檬酸(4.2g/L)、乙醇(19%)、Proclin 300(1ml/L)、1-肉豆蔻酰-2-(4-硝基苯基)琥珀酰基卵磷脂(2.20g/L); 校准品(选配):重组人血小板活化因子乙酰水解酶(批特异,定值见瓶签); 质控品(选配):重组人血小板活化因子乙酰水解酶(批特异,靶值范围见瓶签).
试剂 R1：4-羟乙基哌嗪乙磺酸（HEPES）（11.92g/L）、氯化钠（8.10g/L）、乙二胺四乙酸二钠（0.75g/L）、Proclin 300（1ml/L）； 试剂 R2：一水柠檬酸（4.2g/L）、乙醇（19%）、Proclin 300（1ml/L）、1-肉豆蔻酰-2-（4-硝基苯基）琥珀酰基卵磷脂（2.20g/L）； 校准品（选配）：重组人血小板活化因子乙酰水解酶（批特异，定值见瓶签）； 质控品（选配）：重组人血小板活化因子乙酰水解酶（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。