China NMPA legacy archive 鄂械注准20252405409Heparin-binding protein (HBP) detection reagent kit (fluorescent immunochromatography method)
肝素结合蛋白（HBP）检测试剂盒（荧光免疫层析法）
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：QF1，包装规格：20人份/盒、40人份/盒；型号：AF1，包装规格：15人份/盒、25人份/盒、30人份/盒、50人份/盒；型号：AF2，包装规格：15人份/盒、25人份/盒、30人份/盒、50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20252405409
- 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
本检测试剂适用于体外定量检测人血浆中肝素结合蛋白（HBP）的含量。
Structure and composition
English
试剂盒由测试卡、弹夹（AF1型号和AF2型号适配）、干燥剂和定标卡组成。其中，测试卡由测试卡外壳、硝酸纤维素膜（包被有鼠抗人HBP抗体B和羊抗鼠IgG抗体）、荧光结合垫（包被荧光标记的鼠抗人HBP抗体A）、样本垫、吸水纸、PVC板组成；定标卡包含试剂的校准曲线、批次、项目名称、生产日期信息。（具体内容详见说明书）
Storage conditions and expiration
English
试剂盒应在2℃～30℃干燥环境下避光保存，有效期为18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 Heparin-binding protein (HBP) detection reagent kit (fluorescent immunochromatography method), registration 鄂械注准20252405409. 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.