C-reactive Protein Test Reagent Kit (Chemiluminescent Immunoassay)
- Device class
- Class II
- Model specifications
- 100 servings/box, 200 servings/box100人份/盒、200人份/盒
- Approval department
- Hunan Provincial Drug Administration湖南省药品监督管理局
- Registration number
- 湘械注准20222400067
- Approval date
- January 18, 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
It is used for the quantitative detection of the concentration of C-reactive protein in human serum in vitro.
用于体外定量检测人血清中C反应蛋白的浓度。
Reagent 1: Biotin-labeled C-reactive protein monoclonal antibody (approx. 0.5 mg/L, murine), phosphate buffer (containing 1% bovine serum protein, 0.1% Proclin300, PH7.4); Reagent 2: C-reactive protein monoclonal antibody containing acridine ester (approximately 0.5 mg/L, murine), phosphate buffer (containing 1% bovine serum protein, 0.1% Proclin300, PH7.4); Reagent M: Streptavidin-coated magnetic particles (approximately 0.3 mg/mL) containing 0.1% chloroacetamide; Series calibrators: with C-reactive protein (human), phosphate buffer (with 1% bovine serum protein, 0.1% Proclin300, PH7.4); The concentrations were about 0, 0.5, 5, 20, 50, 100mg/L.
试剂 1:含生物素标记的 C 反应蛋白单克隆抗体(约 0.5mg/L,鼠源性), 磷酸盐缓冲液(含 1%牛血清蛋白,0.1%Proclin300,PH7.4);试剂 2:含吖啶酯标记的 C 反应蛋白单克隆抗体(约 0.5mg/L,鼠源性),磷酸盐缓冲液(含 1%牛血清蛋白,0.1%Proclin300,PH7.4);试剂 M:含链霉亲和素包被的磁颗粒(约 0.3mg/mL),含 0.1% 氯乙酰胺;系列校准品:含 C 反应蛋白(人源性),磷酸盐缓冲液(含 1%牛血清蛋白, 0.1%Proclin300,PH7.4);浓度分别约为:0、0.5、5、20、50、100mg/L。
Store at 2-8°C, valid for 18 months; The opened reagents and calibrators can be stored stably for 60 days at 2-8°C.
2-8℃环境下储存，有效期18个月；开封的试剂及校准品，2-8℃环境下可稳定保存60天。
- 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 Test Reagent Kit (Chemiluminescent Immunoassay) 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20222400067 and owned by Hunan Huaxi Pharmaceutical Co., Ltd.. The device was approved on January 18, 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.