Influenza A/B Virus Antigen Test Kit (Colloidal Gold Method)
- Device class
- Class III
- Model specifications
- 10 servings/box, 20 servings/box, 40 servings/box, 50 servings/box, 100 servings/box10人份/盒、20人份/盒、40人份/盒、 50人份/盒、100人份/盒
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243401660
- Approval date
- September 02, 2024
- Expiry date
- September 01, 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, Yard 20, Chuangzhan Road, Daxing District, Beijing北京市大兴区创展路20号院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
This kit is used for the in vitro qualitative detection of influenza A and B virus antigens in human nasopharyngeal swab and oropharyngeal swab samples.
本试剂盒用于体外定性检测人鼻咽拭子和口咽拭子样本中的甲型和乙型流感病毒抗原。
The kit consists of a test card, a sample extraction solution, a sample extraction tube, a dripper, and an instruction manual. (Please refer to the manual for details)
试剂盒由检测卡、样本提取液、样本提取管、滴头、说明书组成。（具体内容详见说明书）
Store at 4~30°C, avoid wet, hot or frozen storage, valid for 18 months.
4～30℃保存，避免湿、热或冷冻储存，有效期18个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Influenza A/B Virus Antigen Test Kit (Colloidal Gold Method) 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20243401660 and owned by Beijing Beier Bioengineering Co., Ltd.. The device was approved on September 02, 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.