血小板聚集功能二磷酸腺苷(ADP)检测试剂盒(比浊法)
- 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 number
- 京械注准20242400563
- Approval date
- October 18, 2024
- Expiry date
- October 17, 2029
- 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 address
- 北京市昌平区利祥路6号4幢、5幢、6幢
用于体外检测人血浆样本中血小板聚集率.
用于体外检测人血浆样本中血小板聚集率。
试剂盒由R1和R2组成,R1为ADP(冻干品),含150mu;mol/L二磷酸腺苷试剂,R2为ADP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.
试剂盒由R1和R2组成，R1为ADP（冻干品），含150mu;mol/L二磷酸腺苷试剂，R2为ADP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。
2℃~8℃密封避光保存,有效期为12个月.
2℃~8℃密封避光保存，有效期为12个月。
- 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
Access comprehensive regulatory information for 血小板聚集功能二磷酸腺苷(ADP)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20242400563 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.