China NMPA legacy archive 国械注准20243401117丙型肝炎病毒抗体（HCV）对照品
Guangzhou Darui Biotechnology Co., Ltd.Class IIINMPAApproved June 18, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class III
- Model specifications
- 4 bottles, 1.0mL/bottle (lyophilized reconstitution volume)
- Approval department
- State Drug Administration
4瓶，1.0mL/瓶（冻干品复溶体积）
国家药品监督管理局
Registration information
- Registration number
- 国械注准20243401117
- Approval date
- June 18, 2024
- Expiry date
- June 17, 2029
Registrant
- Province/Region
- Guangdong
- Address
- No. 6 Lizhishan Road, Guangzhou High-tech Industrial Development Zone, No. 2 No. 404
广东
广州市高新技术产业开发区荔枝山路6号自编2号404
Production facility
- Production address
- 广州高新技术产业开发区荔枝山路6号，1号楼4楼401-408室；2号楼1楼、4楼
Intended use
English
用于检测丙型肝炎病毒抗体定性项目的临界值校正。
Structure and composition
English
包含HCV抗体阴性对照品和HCV抗体阳性对照品。（具体内容详见产品说明书）
Storage conditions and expiration
English
本校准品于2～8℃保存，有效期为12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 丙型肝炎病毒抗体（HCV）对照品, registration 国械注准20243401117. 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.