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.试剂: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(试剂1:1×600T+试剂2:1×600T）、6×72T(试剂1:6×12.9mL+试剂2:6×12.9mL)、1×72T（试剂1:1×12.9mL+试剂2:1×12.9mL）;校准品(选配):0.5mL×5、1mL×5、2mL×5;质控品(选配):0.5mL×2、1mL×2、2mL×2。
- Approval department
- Hunan Provincial Drug Administration湖南省药品监督管理局
- Registration number
- 湘械注准20232400817
- Approval date
- August 31, 2023
- Expiry date
- August 30, 2028
- Name
- Hunan Yonghe-sun Biotechnology Co., Ltd.湖南永和阳光生物科技股份有限公司
- Province/Region
- Hunan湖南
- Address
- No. 101, Kangtian Road, Liuyang Economic and Technological Development Zone浏阳经济技术开发区康天路101号
- 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
Access comprehensive regulatory information for Hypersensitivity C-reactive protein (hs-CRP) assay kit (latex-enhanced immunoturbidimetry) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 湘械注准20232400817 and owned by Hunan Yonghe-sun Biotechnology Co., Ltd.. The device was approved on August 31, 2023.
This page provides complete registration details including registrant information, province location (Hunan), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.