N末端B型利钠肽前体（NT-proBNP）校准品
- Device class
- Class II
- Model specifications
- C1：0.5 mL，C2：0.5 mL；C1：1.0 mL，C2：1.0 mL；C1：1.5 mL，C2：1.5 mL
- Approval department
- Hubei Provincial Drug Administration湖北省药品监督管理局
- Registration number
- 鄂械注准20252405412
- Approval date
- January 26, 2025
- Expiry date
- January 25, 2030
- Name
- Wuhan Easy Diagnosis Biomedicine Co., Ltd.武汉明德生物科技股份有限公司
- Province/Region
- Hubei湖北
- Address
- No. 388, Gaoxin 2nd Road, Wuhan Donghu New Technology Development Zone, No. 388, Wuhan Optics Valley International Biomedical Enterprise Accelerator Phase 3.1, Building 25, 1-story (3) Plant No. 3武汉东湖新技术开发区高新二路388号武汉光谷国际生物医药企业加速器3.1期25栋1层(3)厂房三号
- Production address
- 1、武汉市东湖开发区高新大道858号光谷生物医药产业园二期A8 2-2栋；2、武汉市东湖新技术开发区高新二路388号武汉光谷国际生物医药企业加速器3.1期25幢1层3、4号房；3、武汉市东湖新技术开发区高新二路388号武汉光谷国际生物医药企业加速器3.1期25幢2层3、4号房
本产品与明德N末端B型利钠肽前体（NT-proBNP）检测试剂盒（磁微粒化学发光免疫分析法）配套使用，适用于对N末端B型利钠肽前体（NT-proBNP）项目进行检测时的校准。
本产品由校准品C1、校准品C2和校准卡组成。其中C1为含浓度约为300 pg/mL的重组N末端B型利钠肽前体（NT-proBNP）的缓冲液，C2为含浓度约为10000 pg/mL的重组N末端B型利钠肽前体（NT-proBNP）的缓冲液，校准卡包含校准品C1和校准品C2浓度信息。（具体内容详见说明书）
校准品应在2～8℃环境储存，有效期12个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for N末端B型利钠肽前体（NT-proBNP）校准品 in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 鄂械注准20252405412 and owned by Wuhan Easy Diagnosis Biomedicine Co., Ltd.. The device was approved on January 26, 2025.
This page provides complete registration details including registrant information, province location (Hubei), 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.