λ Light Chain Assay Kit (Latex Immunoturbidimetry)
- 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20242400444
- 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 lambda in human urine in vitro; The content of light chain (Lambda).
用于体外定量测定人尿液中lambda;轻链(Lambda)的含量。
Composition: Main components: Concentration: Reagent 1 (R1), liquid sodium citrate: 100mmol/L, sodium chloride, 0.15mol/L, preservative, 0.03%, reagent 2 (R2), liquid sodium citrate: 100mmol/L, bovine serum albumin, 1% Tween 201%, preservative: 0.03%, coated with anti-lambda; Light chain antibody latex granules, 0.5% calibrator (optional), lyophilized powder, bovine serum albumin, 2% phosphate buffer, 20mmol/L, preservative, 0.03%, protectant, 5%, sodium chloride, 0.15mol/Llambda; Light chain target concentration range: [10.00, 20.00] mg/L quality control (optional): lyophilized powder, bovine serum albumin, 2% phosphate buffer, 20mmol/L, preservative, 0.03%, protective agent, 5%, sodium chloride, 0.15mol/Llambda; Light chain target concentration range: level 1: [1.00, 5.00] mg/L level 2: [6.00, 14.00] mg/L calibrator target value batch specific, see calibrator bottle label for details; The quality control quality control scope is specific to each batch, see the quality control bottle label for details; The calibrator is traced back to the calibrator of the enterprise's work; The components are not interchangeable in different lot number kits.
组成性状主要成分浓度试剂1(R1)液体柠檬酸钠100mmol/L氯化钠0.15mol/L防腐剂0.03%试剂2(R2)液体柠檬酸钠100mmol/L牛血清白蛋白1%吐温201%防腐剂0.03%包被有抗lambda;轻链抗体胶乳颗粒0.5%校准品(选配)冻干粉牛血清白蛋白2%磷酸盐缓冲液20mmol/L防腐剂0.03%保护剂5%氯化钠0.15mol/Llambda;轻链靶值浓度范围:[10.00,20.00]mg/L质控品(选配)冻干粉牛血清白蛋白2%磷酸盐缓冲液20mmol/L防腐剂0.03%保护剂5%氯化钠0.15mol/Llambda;轻链目标浓度范围:水平1:[1.00,5.00]mg/L水平2:[6.00,14.00]mg/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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