Pure Global AI
China NMPA legacy archive 湘械注准20232400817

Hypersensitivity C-reactive protein (hs-CRP) assay kit (latex-enhanced immunoturbidimetry)

超敏C反应蛋白(hs-CRP)测定试剂盒(胶乳增强免疫比浊法)
Hunan Yonghe-sun Biotechnology Co., Ltd.Class IINMPAApproved August 31, 2023
Static archiveNMPA · legacy registration snapshot
Device classification
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 information
Registration number
湘械注准20232400817
Approval date
August 31, 2023
Expiry date
August 30, 2028
Registrant
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 facility
Production address
浏阳经济技术开发区康天路101号
Intended use
English

This kit is used for the quantitative determination of C-reactive protein content in human serum in vitro.

中文

本试剂盒用于体外定量测定人血清中C反应蛋白的含量。

Structure and composition
English

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.

中文

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。

Storage conditions and expiration
English

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.

中文

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。

Additional information
Appendix
产品技术要求、说明书
About this record

This static archive preserves historical registration fields and translations for Hypersensitivity C-reactive protein (hs-CRP) assay kit (latex-enhanced immunoturbidimetry), registration 湘械注准20232400817. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.