新型冠状病毒（2019-nCoV）、甲型流感病毒、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
- 48 servings/box, 96 servings/box48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20253400082
- Approval date
- January 10, 2025
- Expiry date
- January 09, 2030
- Name
- Zhuhai Livzon Diagnostics INC.珠海丽珠试剂股份有限公司
- Province/Region
- Guangdong广东
- Address
- Building 1, No. 266, Tongchang Road, Xiangzhou District, Zhuhai珠海市香洲区同昌路266号1栋
- Production address
- 珠海市香洲区同昌路 266 号
本产品用于体外定性检测具有新型冠状病毒感染相关症状人群、具有流感症状/体征、流感相似症状或有密切接触史的人群、其他需要进行新型冠状病毒感染诊断或鉴别诊断者的咽拭子中新型冠状病毒（2019-nCOV）的ORF1ab和N基因以及甲型/乙型流感病毒核酸。
本产品由反应试剂、阳性质控品、阴性质控品和矿物油B组成。（具体内容详见产品说明书）
2～28℃保存，有效期12个月
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for 新型冠状病毒（2019-nCoV）、甲型流感病毒、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20253400082 and owned by Zhuhai Livzon Diagnostics INC.. The device was approved on January 10, 2025.
This page provides complete registration details including registrant information, province location (Guangdong), 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.