人细胞角蛋白CK18-M30检测试剂盒（磁微粒化学发光免疫分析法）
- Device class
- Class II
- Model specifications
- 50 servings/box, 100 servings/box50人份/盒、100人份/盒
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20252400047
- Approval date
- January 25, 2025
- Expiry date
- January 24, 2030
- Name
- Beijing Beier Bioengineering Co., Ltd.北京贝尔生物工程股份有限公司
- Province/Region
- Beijing北京
- Address
- No. 99, Chuangcheng Industrial Development Zone, Huangcun Town, Daxing District, Beijing北京市大兴区黄村镇芦城工业开发区创新路99号
- Production address
- 北京市大兴区创展路20号院， 北京市大兴区仲景路15号院1号楼1层、2层202室、4层、5层
本品用于体外定性检测人血清中的细胞角蛋白CK18-M30。
编号名称组成成分50人份/盒100人份/盒1磁微粒混悬液（包被CK18-M30-Ab）含有包被鼠抗人CK18-M30单克隆抗体的磁性微粒，Tris缓冲液（50mmol/L，pH8.0）3mL4mL2酶标工作液（含CK18-M30-Ab-HRP）含有标记鼠抗人CK18-M30单克隆抗体的HRP，Tris缓冲液（50mmol/L，pH8.0）7mL12mL3样品稀释液Tris缓冲液（50mmol/L，pH8.0）7mL12mL4校准品（S1-S6）（含有CK18-M30）含6个水平人源CK18-M30抗原和Tris缓冲液（50mmol/L，pH8.0），目标浓度分别为20、40、80、160、320和640AU/mL1套（每套共六支，1ml/支）
1.试剂盒于2～8℃存放，有效期12个月。 2.开封（开瓶）或使用后剩余组分在2～8℃保存条件下最低稳定期限为30天。 3.生产日期及有效期见外包装盒。
Access comprehensive regulatory information for 人细胞角蛋白CK18-M30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 京械注准20252400047 and owned by Beijing Beier Bioengineering Co., Ltd.. The device was approved on January 25, 2025.
This page provides complete registration details including registrant information, province location (Beijing), 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.