β2-微球蛋白(β2-MG)测定试剂盒(定时散射比浊法)
- Device class
- Class II
- Model specifications
- Packaging specifications for PA120: 50 servings/box, 100 servings/box, 150 servings/box, 200 servings/box, QC 1 (optional), QC 2 (optional), QC 3 (optional), calibrator 1 (optional), calibrator 2 (optional), calibrator 3 (optional); Packaging specifications for PA200: 50 servings/box, 100 servings/box, 150 servings/box, 200 servings/box, QC 1 (optional), QC 2 (optional), QC 3 (optional), calibrator 1 (optional), calibrator 2 (optional), calibrator 3 (optional); Suitable for PA480/PA480A/PA480C/PA480S, PA240/PA240A/ PA240C/PA240S Packing specifications: 25 servings/box, 50 servings/box, 100 servings/box, 150 servings/box, 200 servings/box, 250 servings/box, 300 servings/box, QC 1 (optional), QC 2 (optional), QC 3 (optional), calibrator 1 (optional), calibrator 2 (optional), Calibrator 3 (optional).
- Approval department
- Guangdong Provincial Drug Administration
- Registration number
- 粤械注准20242401281
- Approval date
- September 25, 2024
- Expiry date
- September 24, 2029
- Province/Region
- Guangdong
- Address
- Shenzhen Guangming New District Matian Street Ma Shantou Community Watch Base Geya Science and Technology Park Building 3 4 to 10 floors
- Production address
- 深圳市光明新区马田办事处马山头社区钟表基地格雅科技园3栋4至10层;深圳市光明区马田街道合水口社区第七工业区第三栋厂房A801;广东省东莞市黄江镇田星路39号2栋501室(仅为仓库使用)
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。
- Appendix
- 产品技术要求、说明书
This static archive preserves historical registration fields and translations for β2-微球蛋白(β2-MG)测定试剂盒(定时散射比浊法), registration 粤械注准20242401281. It does not establish current authorization or complete current product details.
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