C-Reactive Protein (CRP) Determination Reagent Kit (Latex-Enhanced Immunoturbidimetric Method)
- Device class
- Class II
- Model specifications
- R1:1×40ml,R2:1×10ml;R1:2×40ml,R2:2×10ml;R1:4×40ml,R2:4×10ml;R1:6×40ml,R2:6×10ml;R1:1×80ml,R2:1×20ml;R1: 2×80ml,R2:2×20ml;R1:4×80ml,R2:4×20ml;R1:6×80ml,R2: 6×20ml;R1:1×4000ml,R2:1×1000ml.R1:1×40ml，R2:1×10ml；R1:2×40ml，R2:2×10ml；R1:4×40ml，R2:4×10ml；R1:6×40ml，R2:6×10ml；R1:1×80ml，R2:1×20ml；R1: 2×80ml，R2:2×20ml；R1:4×80ml，R2:4×20ml；R1:6×80ml，R2: 6×20ml；R1:1×4000ml，R2:1×1000ml。
- Approval department
- Hunan Provincial Drug Administration湖南省药品监督管理局
- Registration number
- 湘械注准20222400034
- Approval date
- March 25, 2022
- Expiry date
- January 13, 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
It is used by medical institutions to quantitatively measure the content of C-reactive protein in human serum in vitro for auxiliary diagnosis.
供医疗机构用于体外定量测定人血清中 C-反应蛋白的含量，作辅助诊断用。
R1: phosphate buffer, surfactant; R2: phosphate buffer, surfactant, anti-human CRP-IgG sensitized latex particle suspension.
R1：磷酸盐缓冲液、表面活性剂；R2：磷酸盐缓冲液、表面活性剂、抗人CRP-IgG致敏乳胶颗粒悬液。
2°C-8°C, 12 months.
2℃-8℃，12 个月。
- Changes
- 变更时间：2022-03-25变更内容：1、变更申请人住所由“湖南省长沙市雨花区振华路519号聚合工业园14栋602房”变更为“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”。2、变更生产地址由“湖南省长沙市雨花区振华路519号聚合工业园14栋602房”变更为“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”。
Access comprehensive regulatory information for C-Reactive Protein (CRP) Determination Reagent Kit (Latex-Enhanced 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20222400034 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.