China NMPA legacy archive 国械注准20253400200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）
Autobio Diagnostics Co., Ltd.Class IIINMPAApproved January 20, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
- 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 information
- Registration number
- 国械注准20253400200
- Approval date
- January 20, 2025
- Expiry date
- January 19, 2030
Registrant
- Province/Region
- Henan
- Address
- No. 87, Jingbei 1st Road, Zhengzhou Economic and Technological Development Zone
河南
郑州经济技术开发区经北一路87号
Production facility
- Production address
- 郑州经济技术开发区经开第十五大街199号
Intended use
English
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。
Structure and composition
English
PCR reaction solution 1, PCR reaction solution 2, proteinase K. (Please refer to the product manual for details)
中文
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）
Storage conditions and expiration
English
2 °C ~ 8 °C storage, valid for 12 months.
中文
2℃～8℃保存，有效期12个月。
Additional information
- Appendix
- 产品技术要求、说明书
About this record
This static archive preserves historical registration fields and translations 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）, registration 国械注准20253400200. It does not establish current authorization or complete current product details.
The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.