抗SSB抗体质控品
- Device class
- Class II
- Model specifications
- 水平1:1.0mL; 1;1.0mL; 2;1.0mL; 5;1.0mL; 10;水平2:1.0mL; 1;1.0mL; 2;1.0mL; 5;1.0mL; 10.水平1：1.0mL;1；1.0mL;2；1.0mL;5；1.0mL;10；水平2：1.0mL;1；1.0mL;2；1.0mL;5；1.0mL;10。
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20242400250
- Approval date
- May 14, 2024
- Expiry date
- May 13, 2029
- Name
- Beijing Bioassay Technologies Corporation北京世纪沃德生物科技有限公司
- Province/Region
- Beijing北京
- Address
- 401, 4th floor, 4th floor, No. 21, Torch Street, Science and Technology Park, Changping District, Beijing北京市昌平区科技园区火炬街21号4幢4层401
- Production address
- 北京市昌平区火炬街28号1号楼一层东侧，北京市中关村科技园昌平园火炬街28号1号楼一层西侧B区
与北京世纪沃德生物科技有限公司生产的抗SSB抗体测定试剂盒（胶乳免疫比浊法）配套使用，用于抗SSB抗体（Anti-SSB）项目的室内质量控制。
组成性状主要成分浓度质控品冻干粉人血清50%磷酸盐缓冲液20mmol/L防腐剂0.03%保护剂5%氯化钠0.15mol/L抗SSB抗体目标浓度范围：水平1：[2.00，50.00]AU/mL水平2：(50.00，200.00]AU/mL质控品质控范围批特异，详见质控品瓶签。
Store at 2°C~8°C in the dark, valid for 18 months.
2℃～8℃避光保存，有效期为18个月。
Access comprehensive regulatory information for 抗SSB抗体质控品 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20242400250 and owned by Beijing Bioassay Technologies Corporation. The device was approved on May 14, 2024.
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.