Gastrin-17 (G-17) assay kit (fluorescent immunoassay chromatography)
- 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 number
- 鄂械注准20252405410
- 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
本检测试剂适用于体外定量检测人血清、血浆、全血中胃泌素17（G-17）的含量。
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G-17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G-17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）
试剂盒应在2℃～30℃干燥环境下避光保存，有效期为18个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Gastrin-17 (G-17) assay kit (fluorescent immunoassay chromatography) 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20252405410 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.