丙型肝炎病毒抗体（HCV）对照品
- Device class
- Class III
- Model specifications
- 4 bottles, 1.0mL/bottle (lyophilized reconstitution volume)4瓶，1.0mL/瓶（冻干品复溶体积）
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243401117
- Approval date
- June 18, 2024
- Expiry date
- June 17, 2029
- Name
- Guangzhou Darui Biotechnology Co., Ltd.广州市达瑞生物技术股份有限公司
- Province/Region
- Guangdong广东
- Address
- No. 6 Lizhishan Road, Guangzhou High-tech Industrial Development Zone, No. 2 No. 404广州市高新技术产业开发区荔枝山路6号自编2号404
- 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
用于检测丙型肝炎病毒抗体定性项目的临界值校正。
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）
本校准品于2～8℃保存，有效期为12个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for 丙型肝炎病毒抗体（HCV）对照品 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20243401117 and owned by Guangzhou Darui Biotechnology Co., Ltd.. The device was approved on June 18, 2024.
This page provides complete registration details including registrant information, province location (Guangdong), 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.