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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) - NMPA Registration 鄂械注准20252405407

Access comprehensive regulatory information 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) 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20252405407 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.

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Class II
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)
NMPA Registration Number: 鄂械注准20252405407
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Pricing
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。

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
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