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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) - NMPA Registration 国械注准20253400200

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.

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Class III
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)
NMPA Registration Number: 国械注准20253400200
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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。

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
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 Facility
Production Address
郑州经济技术开发区经开第十五大街199号
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