甲型流感病毒及乙型流感病毒核酸检测试剂盒(PCR-荧光探针法)
- Device class
- Class III
- Model specifications
- Serves 24 per box.24人份/盒。
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243402101
- Approval date
- October 24, 2024
- Expiry date
- October 23, 2029
- Name
- Beijing Beier Bioengineering Co., Ltd.北京贝尔生物工程股份有限公司
- Province/Region
- Beijing北京
- Address
- 107, 1st floor, Building 1, No. 20 Chuangzhan Road, Daxing District, Beijing北京市大兴区创展路20号院1号楼1层107
- Production address
- 北京市大兴区创展路20号院；北京市大兴区仲景路15号院1号楼1层、2层202室、4层、5层
本试剂盒用于定性检测人咽拭子样本中的甲型流感病毒以及乙型流感病毒RNA.
本试剂盒用于定性检测人咽拭子样本中的甲型流感病毒以及乙型流感病毒RNA。
试剂盒包含PCR反应液A、PCR反应液B、内标、阴性质控品、弱阳性质控品、强阳性质控品.(具体内容详见产品说明书)
试剂盒包含PCR反应液A、PCR反应液B、内标、阴性质控品、弱阳性质控品、强阳性质控品。（具体内容详见产品说明书）
Store at -20°C in the dark, valid for 12 months.
-20℃避光保存，有效期12个月。
- Changes
- 2024-11-06 注册人住所 北京市大兴区黄村镇芦城工业开发区创新路99号 生产地址 北京市大兴区黄村镇芦城工业开发区创新路99号; 变更为：注册人住所 北京市大兴区创展路20号院1号楼1层107 生产地址 北京市大兴区创展路20号院；北京市大兴区仲景路15号院1号楼1层、2层202室、4层、5层
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for 甲型流感病毒及乙型流感病毒核酸检测试剂盒(PCR-荧光探针法) in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20243402101 and owned by Beijing Beier Bioengineering Co., Ltd.. The device was approved on October 24, 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.