λ Light Chain Assay Kit (Latex Immunoturbidimetry) - NMPA Registration 京械注准20242400444
Access comprehensive regulatory information for λ Light Chain Assay Kit (Latex Immunoturbidimetry) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20242400444 and owned by Beijing Bioassay Technologies Corporation. The device was approved on August 22, 2024.
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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。