Pure Global

细胞因子测定试剂盒(磁微粒化学发光法) - NMPA Registration 湘械注准20242401053

Access comprehensive regulatory information for 细胞因子测定试剂盒(磁微粒化学发光法) 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20242401053 and owned by Hunan Yonghe-sun Biotechnology Co., Ltd.. The device was approved on October 31, 2024.

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.

Free Database
Powered by Pure Global AI
NMPA Official Data
Class II
湘械注准20242401053
细胞因子测定试剂盒(磁微粒化学发光法)
细胞因子测定试剂盒(磁微粒化学发光法)
NMPA Registration Number: 湘械注准20242401053
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Use
English

本试剂盒适用于体外定量检测人血清或血浆中的 IL-1β、IL-2、IL-4、IL-5、IL-6、IL-8、IL-10、IL-12p70、IL-15、IL-17A、IL-17F、IL-18、IL-22、IL-23、IL-27、IL-33、TNF-α的含量,主要用于监测机体的免疫状态、炎症反应等.

中文

本试剂盒适用于体外定量检测人血清或血浆中的 IL-1β、IL-2、IL-4、IL-5、IL-6、IL-8、IL-10、IL-12p70、IL-15、IL-17A、IL-17F、IL-18、IL-22、IL-23、IL-27、IL-33、TNF-α的含量,主要用于监测机体的免疫状态、炎症反应等。

Device Classification
Device Class
Class II
Approval Department
Hunan Provincial Drug Administration
湖南省药品监督管理局
Registration Information
Registration Number
湘械注准20242401053
Approval Date
October 31, 2024
Expiry Date
October 30, 2029
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
Storage Conditions and Expiration
English

未开封的试剂在 2℃~8℃条件下保存,有效期为18个月;开封后的试剂 2℃~8℃保存,有效期为4周.未开封校准品、质控品在 2℃~8℃条件下避光保存,有效期为18个月,校准品、质控品复溶后,避光2℃~8℃条件下,可保存2天,仅可冻融一次.

中文

未开封的试剂在 2℃~8℃条件下保存,有效期为18个月;开封后的试剂 2℃~8℃保存,有效期为4周。未开封校准品、质控品在 2℃~8℃条件下避光保存,有效期为18个月,校准品、质控品复溶后,避光2℃~8℃条件下,可保存2天,仅可冻融一次。

Additional Information
Appendix
产品技术要求、说明书