China NMPA legacy archive 鄂械注准20252405408B型钠尿肽前体（PRO-BNP）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
- Model: L type, specifications: 1 serving/strip, 24 servings/box; 1 serving/stick, 60 servings/box; 1 serving/strip, 90 servings/box; 1 serving/stick, 120 servings/box. Model: S type, specifications: 1 person/strip, 24 servings/box; 1 serving/stick, 60 servings/box; 1 serving/strip, 90 servings/box; 1 serving/stick, 120 servings/box.
- Approval department
- Hubei Provincial Drug Administration
型号：L型，规格：1人份/条、24人份/盒；1人份/条、60人份/盒；1人份/条、90人份/盒；1人份/条、120人份/盒。型号：S型，规格：1人份/条、24人份/盒；1人份/条、60人份/盒；1人份/条、90人份/盒；1人份/条、120人份/盒。
湖北省药品监督管理局
Registration information
- Registration number
- 鄂械注准20252405408
- 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
本试剂盒用于定量测定人血清、血浆和全血中N末端B型利钠肽前体（NT-proBNP）的含量。
Structure and composition
English
本试剂盒由磁珠标记物、酶标记物、样本稀释液、发光底物、清洗液、校准品和校准曲线卡组成。其中磁珠标记物为含有包被着NT-proBNP羊单克隆抗体的磁性微粒缓冲液，酶标记物为含有碱性磷酸酶标记NT-proBNP羊单克隆抗体的缓冲液，样本稀释液为pH7.4的磷酸盐缓冲液，发光底物为含有发光底物的缓冲液，清洗液为pH8.7的TRIS缓冲液。校准品为含不同浓度的N末端B型利钠肽前体（NT-proBNP）抗原的缓冲液，校准曲线卡1份。（具体内容详见说明书）
Storage conditions and expiration
English
试剂条应在于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 B型钠尿肽前体（PRO-BNP）检测试剂盒（磁微粒化学发光免疫分析法）, registration 鄂械注准20252405408. 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.