Hypersensitivity C-reactive protein (hs-CRP) assay kit (latex-enhanced immunoturbidimetry)
- Device class
- Class II
- Model specifications
- Reagents: 99mL×6/99mL×2, 99mL×4/99mL×1, 99mL×3/99mL×1, 99mL×2/99mL×1, 99mL×1/33mL×1, 84mL×6/84mL×2, 84mL×4/56mL×2, 84mL×3/84mL×1, 84mL×2/56mL×1, 84mL×1/28mL×1, 60mL×6/20mL×6, 60mL×5/20mL×5、60mL×4/20mL×4、60mL×3/20mL×3、60mL×2/20mL×2、60mL×1/20mL×1、48mL×6/16mL×6、48mL×5/16mL×5、48mL×4/1 6mL×4、48mL×3/16mL×3、48mL×2/16mL×2、48mL×1/16mL×1、45mL×8/20mL×6、 45mL×6/18mL×5、45mL×4/20mL×3、45mL×2/15mL×2 、45mL×1/15mL×1、21mL×5/7mL×5、21mL×4/7mL×4、21mL×3/7mL×3、21mL×2/7mL×2、21mL×1/7mL×1、500T、780T、1120T、1×100T、2×100T、2×200T、4×200T、1×400T, 2× 400T, 600T (reagent 1:1×600T + reagent 2:1×600T), 6×72T (reagent 1:6×12.9mL + reagent 2:6×12.9mL), 1×72T (reagent 1:1×12.9mL + reagent 2:1×12.9mL); Calibrator (optional): 0.5mL×5, 1mL×5, 2mL×5; Controls (optional): 0.5mL×2, 1mL×2, 2mL×2.
- Approval department
- Hunan Provincial Drug Administration
- Registration number
- 湘械注准20232400817
- Approval date
- August 31, 2023
- Expiry date
- August 30, 2028
- Province/Region
- Hunan
- Address
- No. 101, Kangtian Road, Liuyang Economic and Technological Development Zone
- Production address
- 浏阳经济技术开发区康天路101号
This kit is used for the quantitative determination of C-reactive protein content in human serum in vitro.
本试剂盒用于体外定量测定人血清中C反应蛋白的含量。
Reagent 1: Tris-HCl buffer 6 g/L, Tween-20 2.5 g/L, Proclocklin-300 0.5 g/L, Reagent 2: boric acid buffer 1.5 g/L, borax buffer 0.5 g/L, microsphere 1 50 g/L, microsphere 2 20 g/L, EDC 0.02 g/L, CRP antibody 1 0.3 g/L, Proclocklin-300 0.5 g/L, CRP antibody 2 0.2 g/L; calibrator concentration range: [Level 1: (0-10) mg/ L, level 2: (10-30) mg/L, level 3: (30-60) mg/L, level 4: (120-200) mg/L, level 5: (280-400) mg/L], different amounts of CRP antigen, Proclin300 1mL, BSA 10g were added; Concentration range of quality control: [Level 1: (2-18) mg/L, Level 2: (15-35) mg/L], with different amounts of CRP antigen, Proclin300 1mL, BSA 10g.
试剂1:Tris-HCl缓冲液6g/L、吐温-20 2.5g/L、普洛克林-300 0.5g/L;试剂2:硼酸缓冲液 1.5g/L、硼砂缓冲液 0.5g/L、微球1 50g/L、微球2 20g/L、EDC 0.02g/L、CRP抗体1 0.3g/L、普洛克林-300 0.5g/L、CRP抗体2 0.2g/L;校准品浓度范围:[水平1:(0-10)mg/L、水平2:(10-30)mg/L、水平3:(30-60)mg/L、水平4:(120-200)mg/L、水平5:(280-400)mg/L],添加了不同量CRP抗原、Proclin300 1mL、BSA 10g;质控品浓度范围:[水平1:(2-18)mg/L、水平2:(15-35)mg/L],添加了不同量CRP抗原、Proclin300 1mL、BSA 10g。
The reagent is sealed and stored at 2°C~8°C and protected from light, with a validity period of 12 months, the reagent can be stabilized for 28 days at 2°C~8°C after opening, and the calibrator and quality control can be stable for 3 days at 2°C-8°C after opening.
试剂在2℃~8℃密封避光保存,有效期12个月;已开瓶试剂注意避免污染,2℃~8℃可稳定28天;校准品、质控品开封后2℃-8℃可稳定3天。
- Appendix
- 产品技术要求、说明书
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