China NMPA legacy archive 鄂械注准20252405412N末端B型利钠肽前体（NT-proBNP）校准品
Wuhan Easy Diagnosis Biomedicine Co., Ltd.Class IINMPAApproved January 26, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
- 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 information
- Registration number
- 鄂械注准20252405412
- Approval date
- January 26, 2025
- Expiry date
- January 25, 2030
Registrant
- Province/Region
- Hubei
- 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
湖北
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 facility
- 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
Intended use
English
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。
Structure and composition
English
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）
Storage conditions and expiration
English
校准品应在2～8℃环境储存，有效期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 N末端B型利钠肽前体（NT-proBNP）校准品, registration 鄂械注准20252405412. 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.