β2-微球蛋白(β2-MG)测定试剂盒(定时散射比浊法) - NMPA Registration 粤械注准20242401281
Access comprehensive regulatory information for β2-微球蛋白(β2-MG)测定试剂盒(定时散射比浊法) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20242401281 and owned by Genrui Biotech Inc.. The device was approved on September 25, 2024.
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This kit is used for the quantitative determination of β2-microglobulin content in human serum or urine in vitro, and is mainly used to monitor the function of proximal renal tubules in clinical practice.
本试剂盒用于体外定量测定人血清或者尿液中β2-微球蛋白的含量，临床上主要用于监测近端肾小管的功能。
1. Buffer: phosphate buffer 20 mmol/L, sodium chloride 15.8 g/L, preservative Proclin 300 0.1%; 2. Antiserum: 0.1% of rabbit anti-human β2-microglobulin-specific antibody-conjugated latex particles; 3. Quality control (optional): β2-MG antigen is derived from recombinant antigen, diluted in 5% BSA-PBS buffer, the specific target value is shown in the bottle label, with batch specificity; 4. Calibrator (optional): β2-MG antigen is derived from recombinant antigen and diluted in 5% BSA-PBS buffer, see bottle label for specific target value; 5. Magnetic card: Loads the calibration curve information for this batch of reagents.
1. 缓冲液：磷酸盐缓冲液20 mmol/L、氯化钠15.8 g/L、防腐剂Proclin 300 0.1%； 2. 抗血清：兔抗人β2-微球蛋白特异性抗体偶联的乳胶颗粒0.1%； 3. 质控品（选配）：β2-MG抗原来源于重组抗原，稀释于5%BSA-PBS缓冲液，具体靶值见瓶贴，具有批特异性； 4. 校准品（选配）：β2-MG抗原来源于重组抗原，稀释于5%BSA-PBS缓冲液，具体靶值见瓶贴； 5. 磁卡：载入本批次试剂的定标曲线信息。
Before the kit is opened, all reagents (including calibration quality control) can be stored at 2-8°C in the dark for 12 months. Do not freeze. The kit (including calibration quality control) is stored at 2-8°C after opening and can be stable for 30 days; In-machine stability: PA120: Antiserum in machine (2-15 °C) and buffer in machine (2-30 °C) after reagent opening, valid for 7 days, and other applicable instruments in the state of boot up, reagent in machine after opening 2-15 °C, stable for 7 days.
试剂盒未开启前，所有试剂（含校准质控）避光储存于2-8℃，可保存12个月。不可冷冻。 试剂盒（含校准质控）开启后保存于2-8℃，可稳定30天； 在机稳定性：PA120：试剂开封后抗血清在机(2-15℃)，缓冲液在机（2-30℃），有效期7天，其他适用仪器开机状态下，试剂开封后在机2-15℃，可稳定7天。