China NMPA legacy archive 吉械注准20242400608Lipoprotein-Associated Phospholipase A2 Determination Reagent Kit (Latex Immunoturbidimetry Method)
- Device class
- Class II
- Model specifications
- See the product technical requirements for details
- Approval department
- Jilin Provincial Drug Administration
- Registration number
- 吉械注准20242400608
- Approval date
- September 12, 2024
- Expiry date
- September 11, 2029
- Province/Region
- Jilin
- Address
- No. 95, Yunhe Street, Changchun High-tech Industrial Development Zone
- Production address
- 长春市高新技术产业开发区云河街95号
It is used for in vitro quantitative detection of lipoprotein-associated phospholipase A2 content in human serum and plasma samples.
用于体外定量检测人血清、血浆样本中脂蛋白相关磷脂酶A2的含量。
Kit composition Main components Concentration Reagent 1 (R1) Tris(hydroxymethyl)aminomethane buffer ≥10mmol/L Reagent 2(R2) Anti-human lipoprotein-associated phospholipase A2 sensitized latex granules ≥0.05% Calibrator solution containing lipoprotein-associated phospholipase A2 See Label Controls solution containing lipoprotein-associated phospholipase A2 see label
试剂盒组成 主要组成成分 浓度 试剂1（R1） 三（羟甲基）氨基甲烷缓冲液 ≥10mmol/L 试剂2（R2） 抗人脂蛋白相关磷脂酶A2致敏乳胶颗粒 ≥0.05% 校准品 含有脂蛋白相关磷脂酶A2的溶液 见标签 质控品 含有脂蛋白相关磷脂酶A2的溶液 见标签
- Appendix
- 产品技术要求
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