Anti-streptolysin O (ASO) Assay Kit (Timed Scatter Turbidimetry)
- Device class
- Class II
- Model specifications
- PA480/PA480A/PA480C/PA480S; Packing specifications for PA240/PA240A/PA240C/PA240S: 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), calibrator 4 (optional), calibrator 5 (optional), calibrator 6 (optional); 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), calibrator 4 (optional), calibrator 5 (optional), calibrator 6 (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), calibrator 4 (optional), calibrator 5 (optional), calibrator 6 (optional).
- Approval department
- Guangdong Provincial Drug Administration
- Registration number
- 粤械注准20242401300
- Approval date
- September 27, 2024
- Expiry date
- September 26, 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)
It is suitable for in vitro quantitative detection of antistreptolysin O (ASO) content in human serum or plasma. Clinically, it is mainly used as an auxiliary diagnosis of acute rheumatic fever.
适用于体外定量检测人血清或血浆中的抗链球菌溶血素 O(ASO)含量。临床上主要用于急性风湿热的辅助诊断。
1. Buffer: phosphate buffer 20 mmol/L, preservative 0.1%; 2. Antiserum: latex granules of streptococcal hemolysin O; 3 Quality control (optional): ASO diluted in PBS buffer containing BSA; 4 calibrators (optional): ASO diluted in PBS buffer containing BSA; 5 Magnetic card: load the calibration curve information of this batch of reagents.
1缓冲液:磷酸盐缓冲液20 mmol/L,防腐剂0.1%; 2抗血清:链球菌溶血素O的胶乳颗粒; 3质控品(选配):ASO稀释于含BSA的PBS缓冲液; 4校准品(选配):ASO稀释于含BSA的PBS缓冲液; 5磁卡:载入本批次试剂的定标曲线信息。
Before the kit is opened, all reagents can be stored at 2-8°C in the dark for 18 months and cannot be frozen. The kit is stable for 30 days when stored at 2-8°C after opening; PA120 is stable for 7 days after the reagent is opened, with antiserum in machine (2-15°C) and buffer in machine (2-30°C); Other applicable instruments are powered on, and the buffer and antiserum are on the machine (2-15°C) after the reagent is opened, and can be stable for 7 days.
试剂盒未开启前,所有试剂避光储存于 2-8℃,可保存 18 个月,不可冷冻。试剂盒开启后保存于 2-8℃,可稳定 30 天;PA120 开机状态下,试剂开封后抗血清在机(2-15℃),缓冲液在机(2-30℃),可稳定 7 天;其他适用仪器开机状态下,试剂开封后缓冲液和抗血清在机(2-15℃),可稳定 7 天。
- Appendix
- 产品技术要求、说明书
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