超敏C反应蛋白(HS-CRP)测定试剂盒(速率散射比浊法) - NMPA Registration 粤械注准20242401296
Access comprehensive regulatory information for 超敏C反应蛋白(HS-CRP)测定试剂盒(速率散射比浊法) 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20242401296 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 C-reactive protein content in human serum, plasma and whole blood, and is mainly used to evaluate the risk of cardiovascular disease in clinical practice.
适用于体外定量检测人血清、血浆和全血中的C反应蛋白含量，临床上主要用于评价心血管疾病风险。
1. Antiserum: rabbit anti-human CRP antibody-conjugated latex particles; 2. Buffer: phosphate buffer 20 mmol/L, sodium chloride 15.8 g/L; 3. Quality control (optional): CRP antigen is derived from human extraction, diluted in PBS buffer containing 20% calf serum, with batch specificity, see bottle sticker for specific target values; 4. Calibrator (optional): CRP antigen is extracted from human sources, diluted in PBS buffer containing 20% calf serum, and the specific target value is shown on the bottle label; 5. Sample diluent (optional): sodium chloride; 6. Magnetic card: load the calibration curve information of this batch of reagents; 7. Stir bar (optional): suitable for PA300, PA320; 8. Test cup (optional): transparent without impurities (PA300, PA320).
1.抗血清：兔抗人CRP抗体偶联的乳胶颗粒； 2.缓冲液：磷酸盐缓冲液20 mmol/L，氯化钠15.8 g/L； 3.质控品（选配）：CRP抗原来源于人源提取，稀释于含20%小牛血清的PBS缓冲液，具有批特异性，具体靶值见瓶贴； 4.校准品（选配）：CRP抗原来源于人源提取，稀释于含20%小牛血清的PBS缓冲液，具体靶值见瓶贴； 5.样本稀释液（选配）：氯化钠； 6.磁卡：载入本批次试剂的定标曲线信息； 7.搅拌子（选配）：适用于PA300、PA320； 8.测试杯（选配）：透明无杂质（PA300、PA320）。
Store at 2-8 °C and have an expiration date of 12 months. Among them, the buffer and sample diluent are stored at 2-30 °C in the dark and can be stored for 12 months; None of the reagents can be frozen. Stability after opening: antiserum, quality controls, and calibrators can be stored at 2-8°C for 30 days; Buffers and sample dilutions are stable for 30 days when stored at 2-30°C. Stability in the machine: When PA120 is turned on, the antiserum is at 2-15 °C after the reagent is opened, and the buffer and diluent are at 2-30 °C at the machine, which can be stable for 8 days. When other applicable instruments are turned on, the reagent can be stable for 8 days at 2-15 °C after opening.
储存于2-8℃，有效期为12个月。其中缓冲液、样本稀释液避光保存于2-30℃，可保存12个月；试剂均不可冷冻。 开封后的稳定性：抗血清、质控品、校准品保存于2-8℃，可稳定30天；缓冲液、样本稀释液保存于2-30℃时，可稳定30天。 在机稳定性：PA120开机状态下，试剂开封后抗血清在机2-15℃，缓冲液、稀释液在机2-30℃，可稳定8天。其他适用仪器开机状态下，试剂开封后在机2-15℃，可稳定8天。