China NMPA legacy archive 京械注准20242400250抗SSB抗体质控品
Beijing Bioassay Technologies CorporationClass IINMPAApproved May 14, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
- 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.
- Approval department
- Beijing Municipal Drug Administration
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。
北京市药品监督管理局
Registration information
- Registration number
- 京械注准20242400250
- Approval date
- May 14, 2024
- Expiry date
- May 13, 2029
Registrant
- Province/Region
- Beijing
- Address
- 401, 4th floor, 4th floor, No. 21, Torch Street, Science and Technology Park, Changping District, Beijing
北京
北京市昌平区科技园区火炬街21号4幢4层401
Production facility
- 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
Intended use
English
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。
Structure and composition
English
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。
Storage conditions and expiration
English
Store at 2°C~8°C in the dark, valid for 18 months.
中文
2℃～8℃避光保存，有效期为18个月。
About this record
This static archive preserves historical registration fields and translations for 抗SSB抗体质控品, registration 京械注准20242400250. 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.