China NMPA legacy archive 浙械注准20242402068Prothrombin time test kit (coagulation method)
凝血酶原时间检测试剂盒（凝固法）
Medicalsystem Biotechnology Co., Ltd.Class IINMPAApproved December 13, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class II
- Model specifications
- 2mL(试剂:1×2mL);4mL(试剂:2×2mL); 10mL(试剂:2×5mL);50mL(试剂:10×5mL); 10mL(试剂:1×10mL);20mL(试剂:2×10mL); 1×100测试/盒;2×100测试/盒;10×100测试/盒; 1×200测试/盒;2×200测试/盒.
- Approval department
- Zhejiang Provincial Drug Administration
2mL(试剂：1×2mL)；4mL(试剂：2×2mL)； 10mL(试剂：2×5mL)；50mL(试剂：10×5mL)； 10mL(试剂：1×10mL)；20mL(试剂：2×10mL)； 1×100测试/盒；2×100测试/盒；10×100测试/盒； 1×200测试/盒；2×200测试/盒。
浙江省药品监督管理局
Registration information
- Registration number
- 浙械注准20242402068
- Approval date
- December 13, 2024
- Expiry date
- December 12, 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浆中的凝血酶原时间(PT).
中文
用于体外定量测定人血浆中的凝血酶原时间（PT）。
Structure and composition
English
组织因子、氯化钙、牛血清白蛋白、4-羟乙基哌嗪乙磺酸缓冲液.(具体内容详见说明书)
中文
组织因子、氯化钙、牛血清白蛋白、4-羟乙基哌嗪乙磺酸缓冲液。（具体内容详见说明书）
Storage conditions and expiration
English
The kit is stored at 2~8 °C and is valid for 12 months.
中文
试剂盒在2～8℃保存，有效期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 Prothrombin time test kit (coagulation method), registration 浙械注准20242402068. 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.