China NMPA legacy archive 京械注准20242400702Triglyceride Test Kit (GPO-PAP Method)
- Device class
- Class II
- Model specifications
- 500测试/盒;484测试/盒;试剂1:2;41mL、试剂2:2;23mL;试剂1:2;40mL、试剂2:2;22mL.质控品(水平1):1;1mL;质控品(水平2):1;1mL.
- Approval department
- Beijing Municipal Drug Administration
- Registration number
- 京械注准20242400702
- Approval date
- November 12, 2024
- Expiry date
- November 11, 2029
- Province/Region
- Beijing
- Address
- 5th floor, Kuanyi Building, No. 15 Huayuan East Road, Haidian District, Beijing
- Production address
- 北京市怀柔区雁栖经济开发区雁栖北二街15号
本试剂盒用于体外定量测定人血清或血浆中甘油三酯(TG)的含量.
本试剂盒用于体外定量测定人血清或血浆中甘油三酯（TG）的含量。
试剂成分浓度试剂1:Goodrsquo;s缓冲液甘油激酶甘油-3-磷酸氧化酶腺苷三磷酸二钠N-乙基-N-(2-羟基-3-磺丙基)-3-甲基苯胺钠盐(TOOS)100mmol/L3kU/L6kU/L3mmol/L2mmol/L试剂2:Goodrsquo;s缓冲液脂蛋白脂肪酶过氧化物酶4-氨基安替比林100mmol/L6kU/L8kU/L2mmol/L质控品(冻干粉),2水平血清目标浓度范围ge;30%水平1:0.80-1.30mmol/L水平2:1.35-2.55mmol/L注:质控品靶值批特异,详见靶值单;
试剂成分浓度试剂1：Goodrsquo;s缓冲液甘油激酶甘油-3-磷酸氧化酶腺苷三磷酸二钠N-乙基-N-(2-羟基-3-磺丙基)-3-甲基苯胺钠盐（TOOS）100mmol/L3kU/L6kU/L3mmol/L2mmol/L试剂2：Goodrsquo;s缓冲液脂蛋白脂肪酶过氧化物酶4-氨基安替比林100mmol/L6kU/L8kU/L2mmol/L质控品（冻干粉），2水平血清目标浓度范围ge;30%水平1:0.80-1.30mmol/L水平2:1.35-2.55mmol/L注：质控品靶值批特异，详见靶值单；
2℃~ 8℃密封避光保存,有效期12个月.
2℃~ 8℃密封避光保存，有效期12个月。
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