Antithrombin III Determination Test Kit (Chromogenic Substrate Method)
- 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 number
- 浙械注准20252401010
- Approval date
- January 06, 2025
- Expiry date
- January 05, 2030
- 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抗凝血酶Ⅲ（ATⅢ）的活性。
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）
Store at 2~8°C, valid for 18 months.
2～8℃保存，有效期18个月。
- Appendix
- 产品技术要求、说明书
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.