Transferrin determination reagent kit (latex immunoturbidimetric assay) - NMPA Registration 京械注准20242400443
Access comprehensive regulatory information for Transferrin determination reagent kit (latex immunoturbidimetric assay) 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20242400443 and owned by Beijing Bioassay Technologies Corporation. The device was approved on August 22, 2024.
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It is used for in vitro quantitative determination of transferrin (TRF) content in human urine.
用于体外定量测定人尿液中转铁蛋白（TRF）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%, latex particles coated with anti-transferrin antibody, 0.5% calibrator (optional), lyophilized powder, phosphate buffer, 20mmol/L, protective agent, 5%, sodium chloride, 0.15mol/L, preservative: 0.03% Target concentration range of transferrin: [80.00, 120.00] mg/L quality control (optional) lyophilized powder, phosphate buffer 20mmol/L, protective agent 5% sodium chloride 0.15mol/L preservative, 0.03% transferrin target concentration range: level 1: (0.40, 15.00) mg/L level 2: (15.00, 40.00) 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; Calibrators are traceable to international reference materials (number: ERM-DA470k/IFCC); 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%包被有抗转铁蛋白抗体的胶乳颗粒0.5%校准品（选配）冻干粉磷酸盐缓冲液20mmol/L保护剂5%氯化钠0.15mol/L防腐剂0.03%转铁蛋白靶值浓度范围：[80.00，120.00]mg/L质控品（选配）冻干粉磷酸盐缓冲液20mmol/L保护剂5%氯化钠0.15mol/L防腐剂0.03%转铁蛋白目标浓度范围：水平1：（0.40，15.00）mg/L水平2：（15.00，40.00）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；校准品溯源至国际标准物质（编号：ERM-DA470k/IFCC）；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。