Rheumatoid factor (RF) assay kit (timed scatter turbidimetry) - NMPA Registration 粤械注准20242401298
Access comprehensive regulatory information for Rheumatoid factor (RF) 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20242401298 and owned by Genrui Biotech Inc.. The device was approved on September 27, 2024.
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It is used for in vitro quantitative detection of rheumatoid factor content in human serum or plasma samples. Clinically, it is mainly used as an auxiliary diagnosis of rheumatoid arthritis (RA).
用于体外定量检测人血清或血浆样本中的类风湿因子含量。临床上主要用于类风湿关节炎（RA）的辅助诊断。
1. Buffer: phosphate buffer 20 mmol/L, sodium chloride 15.8 g/L; 2. Antiserum: phosphate buffered saline 20 mmol/L, human γ globulin-conjugated latex particles; 3 Quality control (optional): RF diluted in PBS buffer containing BSA; 4 Calibrator (optional): RF diluted in PBS buffer containing BSA; 5 Magnetic card: Loads the calibration curve information for this lot of reagents.
1缓冲液：磷酸盐缓冲液20 mmol/L，氯化钠15.8 g/L； 2抗血清：磷酸盐缓冲液20 mmol/L，人γ球蛋白偶联的乳胶颗粒； 3质控品（选配）：RF稀释于含BSA的PBS缓冲液； 4 校准品（选配）：RF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 should be stored at 2-8°C in the dark for 12 months and cannot be frozen. The kit is stored at 2-8°C after opening and can be stable for 30 days; When PA120 is turned on, the antiserum is in the machine (2-15 °C) and the buffer is in the machine (2-30 °C) after the reagent is opened, which can be stable for 7 days. When other applicable instruments are turned on, the buffer and antiserum are in the machine (2-15°C) after the reagent is opened, and it 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12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。