人表皮生长因子受体2校准品
- Device class
- Class III
- Model specifications
- 1.0 mL×2瓶/盒，1.0 mL×4瓶/盒。
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20253400059
- Approval date
- January 10, 2025
- Expiry date
- January 09, 2030
- Name
- Autobio Diagnostics Co., Ltd.郑州安图生物工程股份有限公司
- Province/Region
- Henan河南
- Address
- No. 87, Jingbei 1st Road, Zhengzhou Economic and Technological Development Zone郑州经济技术开发区经北一路87号
- Production address
- 郑州经济技术开发区经开第十五大街199号
本产品用于本公司全自动化学发光检测仪对人表皮生长因子受体2（HER-2/neu）检测项目进行校准。
由校准品（含人表皮生长因子受体2重组抗原）和条码卡组成。
Store at 2°C~8°C, valid for 18 months.
2℃～8℃储存，有效期18个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for 人表皮生长因子受体2校准品 in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20253400059 and owned by Autobio Diagnostics Co., Ltd.. The device was approved on January 10, 2025.
This page provides complete registration details including registrant information, province location (Henan), 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.