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Coagulation multiple quality control product - NMPA Registration 浙械注准20242402066

Access comprehensive regulatory information for Coagulation multiple quality control product 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20242402066 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20242402066
Coagulation multiple quality control product
凝血多项质控品
NMPA Registration Number: 浙械注准20242402066
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Pricing
Intended Use
English

与本公司生产的相应试剂盒配套使用,用于生化分析仪对抗凝血酶III(AT III)和纤维蛋白溶酶原(PLG)项目的质量控制,或凝血分析仪对以下项目的质量控制:凝血酶原时间(PT),活化部分凝血活酶时间(APTT),纤维蛋白原(FIB),凝血酶时间(TT),抗凝血酶III(AT III)和纤维蛋白溶酶原(PLG).

中文

与本公司生产的相应试剂盒配套使用,用于生化分析仪对抗凝血酶III(AT III)和纤维蛋白溶酶原(PLG)项目的质量控制,或凝血分析仪对以下项目的质量控制:凝血酶原时间(PT),活化部分凝血活酶时间(APTT),纤维蛋白原(FIB),凝血酶时间(TT),抗凝血酶III(AT III)和纤维蛋白溶酶原(PLG)。

Device Classification
Device Class
Class II
Model Specifications
1×1mL(水平1)、1×1mL(水平2)、1×3mL(水平1)、1×3mL(水平2)、2×1mL(水平1、水平2)、2×3mL(水平1、水平2)
1×1mL(水平1)、1×1mL(水平2)、1×3mL(水平1)、1×3mL(水平2)、2×1mL(水平1、水平2)、2×3mL(水平1、水平2)
Approval Department
Zhejiang Provincial Drug Administration
浙江省药品监督管理局
Registration Information
Registration Number
浙械注准20242402066
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

牛血浆,肝素.(具体内容详见说明书)

中文

牛血浆,肝素。(具体内容详见说明书)

Storage Conditions and Expiration
English

质控品在2~8 ℃保存,有效期18个月.

中文

质控品在2~8 ℃保存,有效期18个月。

Additional Information
Appendix
产品技术要求、说明书