Ferritin determination reagent kit (latex enhanced 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20222400073
- 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
It is used by medical institutions to quantitatively determine the content of ferritin Ferrtin in human serum in vitro, for medical institutions to assist diagnosis, not for tumor screening.
供医疗机构用于体外定量测定人血清中的铁蛋白 Ferrtin 的含量,供医疗机构作辅助诊断用,不做肿瘤筛查用。
R1: phosphate buffer, sodium chloride, macrogol 6000, sodium azide; R2: phosphate buffer, murine anti-human ferritin monoclonal antibody sensitized latex particle suspension, sodium azide; Calibrator: phosphate buffer, ferritin, sodium azide; Controls: phosphate buffer, ferritin, sodium azide.
R1:磷酸盐缓冲液、氯化钠、聚乙二醇 6000、叠氮钠;R2:磷酸盐缓冲液、鼠抗人铁蛋白单克隆抗体致敏的乳胶颗粒悬液、叠氮钠;校准品: 磷酸盐缓冲液、铁蛋白、叠氮钠;质控品:磷酸盐缓冲液、铁蛋白、叠氮钠。
Store at 2~8°C, valid for 1 year.
2～8℃储存，有效期为1年。
- 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 Ferritin 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20222400073 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.