China NMPA legacy archive 浙械注准20242402089β-胶原降解产物检测试剂盒(化学发光微粒子免疫检测法)
β-胶原降解产物检测试剂盒（化学发光微粒子免疫检测法）
Medicalsystem Biotechnology Co., Ltd.Class IINMPAApproved December 24, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class II
- Model specifications
- 50 tests/box; 100 tests/box; 200 tests/box; 400 tests/box.
- Approval department
- Zhejiang Provincial Drug Administration
50测试/盒；100测试/盒；200测试/盒；400测试/盒。
浙江省药品监督管理局
Registration information
- Registration number
- 浙械注准20242402089
- Approval date
- December 24, 2024
- Expiry date
- December 23, 2029
Registrant
- Province/Region
- Zhejiang
- Address
- No. 299, Qiming South Road, Yinzhou District, Ningbo
浙江
宁波市鄞州区启明南路299号
Production facility
- Production address
- 宁波市鄞州区下应街道金达南路1228号
Intended use
English
用于体外定量测定人血清中的β-胶原降解产物(β-CrossLaps)的浓度.
中文
用于体外定量测定人血清中的β-胶原降解产物（β-CrossLaps）的浓度。
Structure and composition
English
产品包含标记试剂、固相试剂、校准品、质控品.具体内容详见说明书.
中文
产品包含标记试剂、固相试剂、校准品、质控品。具体内容详见说明书。
Storage conditions and expiration
English
2～8℃保存可稳定12个月.
中文
2～8℃保存可稳定12个月。
Additional information
- Appendix
- 产品技术要求、说明书
About this record
This static archive preserves historical registration fields and translations for β-胶原降解产物检测试剂盒(化学发光微粒子免疫检测法), registration 浙械注准20242402089. 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.