C-Reactive Protein (CRP) Test Kit (Immunoturbidimetric Method)
- Device class
- Class II
- Approval department
- Hunan Provincial Drug Administration湖南省药品监督管理局
- Registration number
- 湘械注准20222400078
- Approval date
- March 25, 2022
- Expiry date
- January 17, 2027
- Name
- Hunan Huaxi Pharmaceutical Co., Ltd.湖南华曦医药有限公司
- Province/Region
- Hunan湖南
- Address
- No. 18 Xiangtai Road, Liuyang Economic and Technological Development Zone, Changsha E Center Phase I, Building A1, 2nd Floor, 2nd Floor Plant 201, 202浏阳经济技术开发区湘台路18号长沙E中心一期A1栋2层201、202号厂房
- Production address
- 浏阳经济技术开发区湘台路18号长沙E中心一期A1栋2层201、202号厂房
For the quantitative detection of C-reactive protein content in whole blood in vitro.
用于体外定量检测全血中的C反应蛋白的含量。
CRP Reagent 1(R1): Trimethylolaminomethane (Tris) buffer 10mmol/L, NaCl≤1%, surfactant ≤1%, preservative≤0.05%; CRP reagent 2(R2): sheep anti-human C-reactive protein monoclonal antibody latex 2g/L, trimethylolaminomethane (Tris) buffer 200mmol/L, preservative≤0.05%; Quality control level 1 and quality control level 2 are light yellow loose body lyophilized powder.
CRP试剂 1(R1):三羟甲基氨基甲烷(Tris)缓冲液10mmol/L,NaCl≤1%, 表面活性剂≤1%,防腐剂≤0.05%; CRP试剂 2(R2):羊抗人C反应蛋白单克隆抗体胶乳2g/L,三羟甲基氨基甲烷(Tris)缓冲液200mmol/L,防腐剂≤0.05%;质控水平1、质控水平2均为淡黄色疏松体冻干粉。
Store at 2~8 °C (not freezing), the validity period is 12 months. After opening the bottle of CRP reagent 1 (R1) and CRP reagent 2 (R2), it is stored at 2~8 °C with a validity period of 30 days, and the quality control level 1 and quality control level 2 are stored in 2~8 °C after reconstitution, and the validity period is 7 days.
2～8℃贮存（不可冷冻），有效期为12个月。CRP试剂 1（R1）、CRP试剂 2（R2）开瓶后，于2～8℃中贮存，有效期为30天，质控水平1、质控水平2复溶后于2～8℃中贮存，有效期为7天。
Access comprehensive regulatory information for C-Reactive Protein (CRP) Test Kit (Immunoturbidimetric Method) 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20222400078 and owned by Hunan Huaxi Pharmaceutical Co., Ltd.. The device was approved on March 25, 2022.
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.