Lipoprotein phospholipase A2 determination reagent kit (rate method) - NMPA Registration 皖械注准20222400113
Access comprehensive regulatory information for Lipoprotein phospholipase A2 determination reagent kit (rate 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 皖械注准20222400113 and owned by Anhui Daqian Bio-Engineering Limited Company. The device was approved on May 24, 2022.
This page provides complete registration details including registrant information, province location (Anhui), 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 in vitro quantitative detection of lipoprotein phospholipase A2 (Lp-PLA2) activity in human serum.
用于体外定量检测人血清中脂蛋白磷脂酶A2（Lp-PLA2）的活性。
Reagent 1 (R1): HEPES buffer 27mmol/L; EDTA-Na2 0.056%; NaCl 32mmol/L; Reagent 2 (R2): acetic acid buffer 20 mmol/L; I-Myristoyl-2-(4-nitrophenylsuccinyl)-SN-propyl-3-phosphocholine, 0.35%; Calibrators (optional): lipoprotein phospholipase A2, phosphate buffer; Controls (optional): lipoprotein phospholipase A2, phosphate buffer.
试剂1（R1）：HEPES缓冲液 27mmol/L；EDTA-Na2 0.056%；氯化钠 32mmol/L；试剂2（R2）：乙酸缓冲液 20mmol/L；I-肉豆蔻酰-2-（4-硝基苯基琥珀酰基）-sn-丙三基-3-磷酸胆碱 0.35%；校准品（选配）：脂蛋白磷脂酶A2、磷酸盐缓冲液；质控品（选配）：脂蛋白磷脂酶A2、磷酸盐缓冲液。
Storage at 2 °C ~ 8 °C in the dark can be stable for 18 months to prevent freezing. After opening, it can be stable for 30 days when stored at 2 °C ~ 8 °C.
2℃～8℃避光贮存可稳定18个月，防止冷冻。开瓶后于2℃～8℃贮存可稳定30天。