Hypersensitivity C-reactive protein (hs-CRP) assay kit (latex-enhanced immunoturbidimetry) - NMPA Registration 湘械注准20232400817
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.
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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。