China NMPA legacy archive 鲁械注准20242400885Lipoprotein-associated phospholipase A2 assay kit (enzymatic)
- Device class
- Class II
- Model specifications
- R1:80mL×1 R2:20mL×1;R1:60mL×4 R2:30mL×2; R1:80mL×2 R2:20mL×2;R1:40mL×2 R2:20mL×1; R1:50mL×4 R2:50mL×1;R1:40mL×2 R2:10mL×2; R1:60mL×1 R2:15mL×1;R1:40mL×1 R2:10mL×1; R1:20mL×1 R2:5mL×1; 100测试/盒;200测试/盒;300测试/盒; 400测试/盒;600测试/盒;1200测试/盒; 校准品(选配):1mL×1; 质控品(选配):质控品水平1:1mL×1;质控品水平2:1mL×1.
- Approval department
- Shandong Provincial Drug Administration
- Registration number
- 鲁械注准20242400885
- Approval date
- September 23, 2024
- Expiry date
- September 22, 2029
- Province/Region
- Shandong
- Address
- No. 369, Hedong Road, Qingdao High-tech Industrial Development Zone
- Production address
- 青岛高新技术产业开发区河东路369号
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。
- Appendix
- 产品技术要求、说明书
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