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）
- 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.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。
- Approval department
- Hubei Provincial Drug Administration湖北省药品监督管理局
- Registration number
- 鄂械注准20252405408
- 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。
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）
试剂条应在于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 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） 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20252405408 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.