China NMPA legacy archive 鲁械注准20242401055Lipoprotein-Associated Phospholipase A2 (Lp-PLA2) Detection Kit (Latex-Enhanced Immuno Turbidimetric Method)
- 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×5(5水平); 质控品(选配):1mL×2(2水平).
- Approval department
- Shandong Provincial Drug Administration
- Registration number
- 鲁械注准20242401055
- Approval date
- December 02, 2024
- Expiry date
- December 01, 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
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。
- Appendix
- 产品技术要求、说明书
This static archive preserves historical registration fields and translations for Lipoprotein-Associated Phospholipase A2 (Lp-PLA2) Detection Kit (Latex-Enhanced Immuno Turbidimetric Method), registration 鲁械注准20242401055. It does not establish current authorization or complete current product details.
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