Influenza A/B virus and respiratory syncytial virus nucleic acid combined detection kit (fluorescence PCR method)
- Device class
- Class III
- Model specifications
- 1 servings/box, 3 servings/box, 6 servings/box, 12 servings/box, 24 servings/box, 48 people/box, 96 servings/box.1 人份/盒、3 人份/盒、6 人份/盒、12 人份/盒、24 人份/盒、48 人份/盒、96 人份/盒。
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243401718
- Approval date
- September 10, 2024
- Expiry date
- September 09, 2029
- Name
- Getein Biotech, Inc.基蛋生物科技股份有限公司
- Province/Region
- Jiangsu江苏
- Address
- No. 9, Bofu Road, Yanjiang Industrial Development Zone, Liuhe District, Nanjing南京市六合区沿江工业开发区博富路9号
- Production address
- 南京市六合区沿江工业开发区博富路9号;南京市江北新区科丰路6号
This kit is used for the qualitative detection of influenza A virus, influenza B virus and respiratory syncytial virus nucleic acid in human throat swab samples.
本试剂盒用于定性检测人咽拭子样本中的甲型流感病毒、乙型流感病毒和呼吸道合胞病毒核酸。
FluA/FluB/RSV Test Card, FluA/FluB/RSV Positive Control, FluA/FluB/RSV Negative Control, and the kit also includes a single-use virus sampling tube. (Please refer to the product manual for details)
FluA/FluB/RSV检测卡、FluA/FluB/RSV阳性对照、FluA/FluB/RSV阴性对照，试剂盒还包含一次性使用病毒采样管。（具体内容详见产品说明书）
The kit should be stored at 2~28°C in the dark, and the validity period is 12 months.
试剂盒应在2~28℃避光储存，有效期12个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Influenza A/B virus and respiratory syncytial virus nucleic acid combined detection kit (fluorescence PCR 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20243401718 and owned by Getein Biotech, Inc.. The device was approved on September 10, 2024.
This page provides complete registration details including registrant information, province location (Jiangsu), 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.