Anti-streptolysin O (ASO) Assay Kit (Timed Scatter Turbidimetry) - NMPA Registration 粤械注准20242401300
Access comprehensive regulatory information for Anti-streptolysin O (ASO) Assay Kit (Timed Scatter Turbidimetry) 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20242401300 and owned by Genrui Biotech Inc.. The device was approved on September 27, 2024.
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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。