铜绿假单胞菌/流感嗜血杆菌/大肠埃希菌核酸检测试剂盒（PCR-荧光探针法）
- Device class
- Class III
- Model specifications
- 24测试/盒（A），48测试/盒（A），96测试/盒（A）。
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20253400200
- Approval date
- January 20, 2025
- Expiry date
- January 19, 2030
- Name
- Autobio Diagnostics Co., Ltd.郑州安图生物工程股份有限公司
- Province/Region
- Henan河南
- Address
- No. 87, Jingbei 1st Road, Zhengzhou Economic and Technological Development Zone郑州经济技术开发区经北一路87号
- Production address
- 郑州经济技术开发区经开第十五大街199号
本试剂盒用于体外定性检测痰液样本中的铜绿假单胞菌/流感嗜血杆菌/大肠埃希菌核酸。
PCR reaction solution 1, PCR reaction solution 2, proteinase K. (Please refer to the product manual for details)
PCR反应液1、PCR反应液2、蛋白酶K。（具体内容详见产品说明书）
2 °C ~ 8 °C storage, valid for 12 months.
2℃～8℃保存，有效期12个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for 铜绿假单胞菌/流感嗜血杆菌/大肠埃希菌核酸检测试剂盒（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20253400200 and owned by Autobio Diagnostics Co., Ltd.. The device was approved on January 20, 2025.
This page provides complete registration details including registrant information, province location (Henan), 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.