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Antithrombin III Determination Test Kit (Chromogenic Substrate Method) - NMPA Registration 浙械注准20252401010

Access comprehensive regulatory information for Antithrombin III Determination Test Kit (Chromogenic Substrate 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20252401010 and owned by Medicalsystem Biotechnology Co., Ltd.. The device was approved on January 06, 2025.

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20252401010
Antithrombin III Determination Test Kit (Chromogenic Substrate Method)
抗凝血酶Ⅲ检测试剂盒(发色底物法)
NMPA Registration Number: 浙械注准20252401010
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Pricing
Intended Use
English

用于体外定量测定人血浆中的抗凝血酶Ⅲ(ATⅢ)的活性。

Device Classification
Device Class
Class II
Model Specifications
5mL(试剂1:1×4mL+ 试剂2:1×1mL); 10mL(试剂1:2×4mL+ 试剂2:2×1mL); 20mL(试剂1:2×8mL+ 试剂2:2×2mL); 100mL(试剂1:10×8mL+ 试剂2:10×2mL); 20mL(试剂1:1×16mL+ 试剂2:1×4mL); 40mL(试剂1:2×16mL+ 试剂2:2×4mL); 200mL(试剂1:10×16mL+ 试剂2:10×4mL); 50mL(试剂1:1×40mL+ 试剂2:1×10mL); 100mL(试剂1:2×40mL+ 试剂2:2×10mL); 75mL(试剂1:1×60mL+ 试剂2:1×15mL); 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20252401010
Approval Date
January 06, 2025
Expiry Date
January 05, 2030
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

试剂1:Xa因子、肝素、三羟甲基氨基甲烷(Tris)缓冲液; 试剂2:乙酰-D-精氨酰-甘氨酰基-L-精氨酰-p-硝基酰苯胺·二盐酸盐; 校准品:牛血浆; 质控品(水平1、水平2):牛血浆。(具体内容详见说明书)

Storage Conditions and Expiration
English

Store at 2~8°C, valid for 18 months.

中文

2~8℃保存,有效期18个月。

Additional Information
Appendix
产品技术要求、说明书