China NMPA legacy archive 京械注准20242400447Direct bilirubin determination reagent kit (bilirubin oxidase method)
- Device class
- Class II
- Model specifications
- 试剂1:16mL; 1,试剂2:4mL; 1试剂1:16mL; 2,试剂2:4mL; 2试剂1:16mL; 3,试剂2:4mL; 3试剂1:16mL; 8,试剂2:4mL; 8试剂1:20mL; 8,试剂2:5mL; 8试剂1:40mL; 1,试剂2:10mL; 1试剂1:40mL; 2,试剂2:10mL; 2试剂1:40mL; 3,试剂2:15mL; 2试剂1:40mL; 4,试剂2:40mL; 1试剂1:48mL; 2,试剂2:12mL; 2试剂1:48mL; 3,试剂2:12mL; 3试剂1:48mL; 4,试剂2:12mL; 4试剂1:48mL; 2,试剂2:24mL; 1试剂1:48mL; 4,试剂2:24mL; 2试剂1:50mL; 2,试剂2:25mL; 1试剂1:50mL; 4,试剂2:25mL; 2试剂1:50mL; 4,试剂2:50mL; 1试剂1:60mL; 1,试剂2:15mL; 1试剂1:60mL; 2,试剂2:15mL; 2试剂1:60mL; 3,试剂2:15mL; 3试剂1:60mL; 3,试剂2:45mL; 1试剂1:60mL; 6,试剂2:45mL; 2试剂1:60mL; 4,试剂2:60mL; 1试剂1:80mL; 1,试剂2:20mL; 1试剂1:80mL; 2,试剂2:20mL; 2试剂1:80mL; 3,试剂2:20mL; 3试剂1:80mL; 4,试剂2:20mL; 4试剂1:100mL; 4,试剂2:100mL; 1试剂1:4L; 1,试剂2:1L; 1试剂1:5L; 4,试剂2:5L; 1试剂1:5L; 8,试剂2:5L; 2试剂1:20mL; 1,试剂2:5mL; 1校准品(选配):1.0mL; 1;1.0mL; 2;1.0mL; 5;1.0mL; 10质控品(选配):水平1:1.0mL; 1;1.0mL; 2;1.0mL; 5;1.0mL; 10水平2:1.0mL; 1;1.0mL; 2;1.0mL; 5;1.0mL; 10
- Approval department
- Beijing Municipal Drug Administration
- Registration number
- 京械注准20242400447
- Approval date
- August 22, 2024
- Expiry date
- August 21, 2029
- Province/Region
- Beijing
- Address
- 401, 4th floor, 4th floor, No. 21, Torch Street, Science and Technology Park, Changping District, Beijing
- Production address
- 北京市昌平区火炬街28号1号楼一层东侧，北京市中关村科技园昌平园火炬街28号1号楼一层西侧B区
It is used for the quantitative determination of direct bilirubin (DBIL) content in human serum and plasma in vitro.
用于体外定量测定人血清、血浆中直接胆红素（DBIL）的含量。
组成性状主要成分浓度试剂1(R1)液体邻苯二甲酸氢钾120mmol/L乙二胺四乙酸二钠盐2mmol/L抗坏血酸氧化酶1000U/L防腐剂0.03%试剂2(R2)液体邻苯二甲酸氢钾120mmol/L胆红素氧化酶5KU/L防腐剂0.03%校准品(选配)冻干粉磷酸盐缓冲液20mmol/L保护剂5%氯化钠0.15mmol/L防腐剂0.03%胆红素靶值浓度范围:(20.00,60.00)mu; mol/L质控品(选配)冻干粉磷酸盐缓冲液20mmol/L保护剂5%氯化钠0.15mmol/L防腐剂0.03%胆红素目标浓度范围:水平1:(1.00,19.00)mu; mol/L水平2:(70.00,130.00)mu; mol/L校准品靶值批特异,详见校准品瓶签;质控品质控范围批特异,详见质控品瓶签. 校准品溯源至企业工作校准品. 不同批号试剂盒中各组分不能互换.
组成性状主要成分浓度试剂1（R1）液体邻苯二甲酸氢钾120mmol/L乙二胺四乙酸二钠盐2mmol/L抗坏血酸氧化酶1000U/L防腐剂0.03%试剂2（R2）液体邻苯二甲酸氢钾120mmol/L胆红素氧化酶5KU/L防腐剂0.03%校准品（选配）冻干粉磷酸盐缓冲液20mmol/L保护剂5%氯化钠0.15mmol/L防腐剂0.03%胆红素靶值浓度范围：（20.00，60.00）mu;mol/L质控品（选配）冻干粉磷酸盐缓冲液20mmol/L保护剂5%氯化钠0.15mmol/L防腐剂0.03%胆红素目标浓度范围：水平1:（1.00，19.00）mu;mol/L水平2:（70.00，130.00）mu;mol/L校准品靶值批特异，详见校准品瓶签；质控品质控范围批特异，详见质控品瓶签。校准品溯源至企业工作校准品。不同批号试剂盒中各组分不能互换。
Store at 2°C~8°C in the dark, valid for 18 months.
2℃～8℃避光保存，有效期为18个月。
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