China NMPA legacy archive 国械注准20253400059人表皮生长因子受体2校准品
Autobio Diagnostics Co., Ltd.Class IIINMPAApproved January 10, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
- 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 information
- Registration number
- 国械注准20253400059
- Approval date
- January 10, 2025
- Expiry date
- January 09, 2030
Registrant
- Province/Region
- Henan
- Address
- No. 87, Jingbei 1st Road, Zhengzhou Economic and Technological Development Zone
河南
郑州经济技术开发区经北一路87号
Production facility
- Production address
- 郑州经济技术开发区经开第十五大街199号
Intended use
English
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。
Structure and composition
English
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。
Storage conditions and expiration
English
Store at 2°C~8°C, valid for 18 months.
中文
2℃～8℃储存，有效期18个月。
Additional information
- Appendix
- 产品技术要求、说明书
About this record
This static archive preserves historical registration fields and translations for 人表皮生长因子受体2校准品, registration 国械注准20253400059. It does not establish current authorization or complete current product details.
The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.