China NMPA legacy archive 国械注准20243401718Influenza 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.
- Approval department
- State Drug Administration
- Registration number
- 国械注准20243401718
- Approval date
- September 10, 2024
- Expiry date
- September 09, 2029
- Province/Region
- Jiangsu
- Address
- No. 9, Bofu Road, Yanjiang Industrial Development Zone, Liuhe District, Nanjing
- 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
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