China NMPA legacy archive 浙械注准20242402088骨钙素N端中分子片段检测试剂盒(化学发光微粒子免疫检测法)
骨钙素N端中分子片段检测试剂盒（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20242402088
- 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骨钙素N端中分子片段(N-MID Osteocalcin)的浓度.
中文
用于体外定量测定人血清中的骨钙素N端中分子片段（N-MID Osteocalcin）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 骨钙素N端中分子片段检测试剂盒(化学发光微粒子免疫检测法), registration 浙械注准20242402088. 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.