Prothrombin time test kit (coagulation method)
- 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.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浙江省药品监督管理局
- Registration number
- 浙械注准20242402068
- Approval date
- December 13, 2024
- Expiry date
- December 12, 2029
- Name
- Medicalsystem Biotechnology Co., Ltd.美康生物科技股份有限公司
- Province/Region
- Zhejiang浙江
- Address
- No. 299, Qiming South Road, Yinzhou District, Ningbo宁波市鄞州区启明南路299号
- Production address
- 宁波市鄞州区下应街道金达南路1228号
用于体外定量测定人血浆中的凝血酶原时间(PT).
用于体外定量测定人血浆中的凝血酶原时间（PT）。
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)
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）
The kit is stored at 2~8 °C and is valid for 12 months.
试剂盒在2～8℃保存，有效期12个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Prothrombin time test kit (coagulation method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 浙械注准20242402068 and owned by Medicalsystem Biotechnology Co., Ltd.. The device was approved on December 13, 2024.
This page provides complete registration details including registrant information, province location (Zhejiang), 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.