China NMPA legacy archive 鄂械注准20252405411Soluble Growth Stimulated Expression Gene 2 Protein (ST2) Assay Kit (Fluorescence Immunoassay)
可溶性生长刺激表达基因2蛋白（ST2）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20252405411
- 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清、血浆、全血中可溶性生长刺激表达基因2蛋白（ST2）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ST2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ST2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 Soluble Growth Stimulated Expression Gene 2 Protein (ST2) Assay Kit (Fluorescence Immunoassay), registration 鄂械注准20252405411. 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.