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China NMPA legacy archive 鄂械注准20252405407

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）

Wuhan Easy Diagnosis Biomedicine Co., Ltd.Class IINMPAApproved January 26, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
型号：CP1，规格：25人份/盒、50人份/盒、100人份/盒、2×100人份/盒
Approval department
Hubei Provincial Drug Administration
湖北省药品监督管理局
Registration information
Registration number
鄂械注准20252405407
Approval date
January 26, 2025
Expiry date
January 25, 2030
Registrant
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 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

本试剂盒用于定量测定人血清和血浆中N端-B型钠尿肽前体（NT-ProBNP）的含量。

Structure and composition
English

本试剂盒由磁微粒（R1）、酶标抗体（R2）、开孔器和条码卡组成。其中磁微粒（R1）为含有包被着NT- proBNP羊单克隆抗体的磁性微粒缓冲液，酶标抗体（R2）为含有碱性磷酸酶标记的NT- proBNP羊单克隆抗体缓冲液，条码卡包含试剂主校准曲线、项目名称、批次、效期信息。（具体内容详见说明书）

Storage conditions and expiration
English

The kit should be stored at 2~8 °C with a validity period of 12 months.

中文

试剂盒应在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）检测试剂盒（磁微粒化学发光免疫分析法）, registration 鄂械注准20252405407. 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.