胰岛素样生长因子结合蛋白-1(IGFBP-1) 检测试剂盒(胶体金法)
- Device class
- Class II
- Model specifications
- 1 serving/box; 20 servings/box1人份/盒；20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20242405319
- Approval date
- December 25, 2024
- Expiry date
- December 24, 2029
- 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
- 武汉市东湖新技术开发区九龙中路77号
本试剂盒适用于定性检测人体阴道分泌物中胰岛素样生长因子结合蛋白-1(IGFBP-1).
本试剂盒适用于定性检测人体阴道分泌物中胰岛素样生长因子结合蛋白-1（IGFBP-1）。
试剂盒由试纸条和稀释液组成,试纸条由:硝酸纤维素膜(包被有鼠抗人IGFBP-1单克隆抗体B和羊抗鼠IgG抗体)、化学偶合物垫片(喷有金标记的鼠抗人IGFBP-1单克隆抗体A)、样本吸收垫片、液体吸收垫片组成,每份试剂含1份样品稀释液,稀释液由含1%曲拉通的生理盐水组成.
试剂盒由试纸条和稀释液组成，试纸条由：硝酸纤维素膜（包被有鼠抗人IGFBP-1单克隆抗体B和羊抗鼠IgG抗体）、化学偶合物垫片（喷有金标记的鼠抗人IGFBP-1单克隆抗体A）、样本吸收垫片、液体吸收垫片组成，每份试剂含1份样品稀释液，稀释液由含1%曲拉通的生理盐水组成。
The kit should be stored at 4-25°C under sealed conditions and valid for 1 year.
试剂盒应在密封条件下，4-25℃贮存，有效期1年。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for 胰岛素样生长因子结合蛋白-1(IGFBP-1) 检测试剂盒(胶体金法) 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20242405319 and owned by Wuhan Easy Diagnosis Biomedicine Co., Ltd.. The device was approved on December 25, 2024.
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.