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血小板聚集功能花生四烯酸(AA)检测试剂盒(比浊法) - NMPA Registration 京械注准20242400564

Access comprehensive regulatory information for 血小板聚集功能花生四烯酸(AA)检测试剂盒(比浊法) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20242400564 and owned by Beijing Lepu Medical Technology Co., Ltd.. The device was approved on October 18, 2024.

This page provides complete registration details including registrant information, province location (Beijing), 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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Class II
京械注准20242400564
血小板聚集功能花生四烯酸(AA)检测试剂盒(比浊法)
血小板聚集功能花生四烯酸(AA)检测试剂盒(比浊法)
NMPA Registration Number: 京械注准20242400564
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Intended Use
English

用于体外检测人血浆样本中血小板聚集率.

中文

用于体外检测人血浆样本中血小板聚集率。

Device Classification
Device Class
Class II
Model Specifications
组分规格1规格2规格3规格4规格5规格6规格7R11;0.5mL2;0.5mL4;0.5mL5;0.5mL6;0.5mL8;0.5mL10;0.5mLR21;5mL1;5mL1;5mL1;5mL1;5mL1;5mL2;5mL规格8规格9规格10规格11规格12规格13规格14R11;1mL2;1mL4;1mL5;1mL6;1mL8;1mL10;1mLR21;5mL1;5mL1;5mL1;5mL2;5mL2;5mL2;5mL规格15规格16规格17规格18规格19规格20规格21R11;2mL2;2mL4;2mL5;2mL6;2mL8;2mL10;2mLR21;5mL1;5mL2;5mL2;5mL3;5mL4;5mL4;5mL
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20242400564
Approval Date
October 18, 2024
Expiry Date
October 17, 2029
Registrant
Name
Beijing Lepu Medical Technology Co., Ltd.
北京乐普诊断科技股份有限公司
Province/Region
Beijing
北京
Address
No. 37, Chaoqian Road, Science and Technology Park, Changping District, Beijing
北京市昌平区科技园区超前路37号
Production Facility
Production Address
北京市昌平区利祥路6号4幢、5幢、6幢
Structure and Composition
English

试剂盒由R1和R2组成,R1为AA(冻干品),含5mg/mL花生四烯酸试剂,R2为AA复溶液,含0.9%氯化钠.注:不同批号试剂盒中各组分不可互换.

中文

试剂盒由R1和R2组成,R1为AA(冻干品),含5mg/mL花生四烯酸试剂,R2为AA复溶液,含0.9%氯化钠。注:不同批号试剂盒中各组分不可互换。

Storage Conditions and Expiration
English

2℃~8℃密封避光保存,有效期为12个月.

中文

2℃~8℃密封避光保存,有效期为12个月。

Additional Information
Changes
产品过期日期变更为:2℃~8℃密封避光保存,有效期为12个月。。
Appendix
产品技术要求、说明书