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Prothrombin time test kit (coagulation method) - NMPA Registration 浙械注准20242402068

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.

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NMPA Official Data
Class II
浙械注准20242402068
Prothrombin time test kit (coagulation method)
凝血酶原时间检测试剂盒(凝固法)
NMPA Registration Number: 浙械注准20242402068
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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)。

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.
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 Information
Registration Number
浙械注准20242402068
Approval Date
December 13, 2024
Expiry Date
December 12, 2029
Registrant
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 Facility
Production Address
宁波市鄞州区下应街道金达南路1228号
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