超敏C反应蛋白(HS-CRP)测定试剂盒(速率散射比浊法)
- Device class
- Class II
- Model specifications
- Applicable instrument PA120 packaging specifications: 50 servings/box, 100 servings/box, 150 servings/box, 200 servings/box, quality control level 1 (optional), quality control level 2 (optional), quality control level 3 (optional), calibrator 1 (optional), calibrator 2 (optional), calibrator 3 (optional), calibrator 4 (optional), calibrator 5 (optional); Applicable instrument PA200 packaging specifications: 50 servings/box, 100 servings/box, 150 servings/box, 200 servings/box, quality control level 1 (optional), quality control level 2 (optional), quality control level 3 (optional), calibrator 1 (optional), calibrator 2 (optional), calibrator 3 (optional), calibrator 4 (optional), calibrator 5 (optional); Applicable instrument PA300 and PA320 packaging specifications: 50 servings/box, 80 servings/box, 100 servings/box, 120 servings/box, 140 servings/box, 160 servings/box, 180 servings/box, 200 servings/box, 220 servings/box, 240 servings/box, 280 servings/box, 300 copies/box, 400 servings/box, 500 servings/box, buffer (optional), sample diluent (optional), quality control level 1 (optional), Control Level 2 (Optional), Control Level 3 (Optional), Calibrator 1 (Optional), Calibrator 2 (Optional), Calibrator 3 (Optional), Calibrator 4 (Optional), Calibrator 5 (Optional); Applicable instruments PA480, PA480A, PA480C, PA480S, PA240, PA240A, PA240C, PA240S Packing specifications: 50 servings/box, 80 servings/box, 100 servings/box, 120 servings/box, 140 servings/box, 160 servings/box, 180 servings/box, 200 servings/box, 220 servings/box, 240 servings/box, 280 servings/box, 300 servings/box, 400 servings/box, 500 servings/box, control level 1 (optional), control level 2 (optional), control level 3 (optional), calibrator 1 (optional), calibrator 2 (optional), calibrator 3 (optional), calibrator 4 (optional), calibrator 5 (optional).适用仪器PA120的包装规格:50人份/盒、100人份/盒、150人份/盒、200人份/盒,质控品水平1(选配)、质控品水平2(选配)、质控品水平3(选配)、校准品1(选配)、校准品2(选配)、校准品3(选配)、校准品4(选配)、校准品5(选配);适用仪器PA200的包装规格:50人份/盒、100人份/盒、150人份/盒、200人份/盒,质控品水平1(选配)、质控品水平2(选配)、质控品水平3(选配)、校准品1(选配)、校准品2(选配)、校准品3(选配)、校准品4(选配)、校准品5(选配);适用仪器PA300、PA320的包装规格:50人份/盒、80人份/盒、100人份/盒、120人份/盒、140人份/盒、160人份/盒、180人份/盒、200人份/盒、220人份/盒、240人份/盒、280人份/盒、300人份/盒、400人份/盒、500人份/盒,缓冲液(选配)、样本稀释液(选配)、质控品水平1(选配)、质控品水平2(选配)、质控品水平3(选配)、校准品1(选配)、校准品2(选配)、校准品3(选配)、校准品4(选配)、校准品5(选配);适用仪器PA480、PA480A、PA480C、PA480S、PA240、PA240A、PA240C、PA240S包装规格:50人份/盒、80人份/盒、100人份/盒、120人份/盒、140人份/盒、160人份/盒、180人份/盒、200人份/盒、220人份/盒、240人份/盒、280人份/盒、300人份/盒、400人份/盒、500人份/盒,质控品水平1(选配)、质控品水平2(选配)、质控品水平3(选配)、校准品1(选配)、校准品2(选配)、校准品3(选配)、校准品4(选配)、校准品5(选配)。
- Approval department
- Guangdong Provincial Drug Administration广东省药品监督管理局
- Registration number
- 粤械注准20242401296
- Approval date
- September 27, 2024
- Expiry date
- September 26, 2029
- Name
- Genrui Biotech Inc.深圳市锦瑞生物科技股份有限公司
- Province/Region
- Guangdong广东
- Address
- Shenzhen Guangming New District Matian Street Ma Shantou Community Watch Base Geya Science and Technology Park Building 3 4 to 10 floors深圳市光明新区马田街道马山头社区钟表基地格雅科技园3栋4至10层
- 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 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。
- Appendix
- 产品技术要求、说明书
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