Fully automated nucleic acid amplification analyzer - NMPA Registration 国械注准20243220377
Access comprehensive regulatory information for Fully automated nucleic acid amplification analyzer 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20243220377 and owned by Getein Biotech, Inc.. The device was approved on February 21, 2024.
This page provides complete registration details including registrant information, province location (Jiangsu), 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.
The product is based on the principle of real-time fluorescent polymerase chain reaction and is used in conjunction with supporting detection reagents for the extraction and qualitative detection of analytes derived from swab samples, including pathogen items.
该产品基于实时荧光聚合酶链式反应原理，与配套的检测试剂共同使用，在临床上用于对来源于拭子样本中的被分析物进行提取及定性检测，包括病原体项目。
The automatic nucleic acid amplification analyzer is composed of a heating system, an optical path system, a detection system, a main control display system, a printer system, a power supply system, and random software (release version V1.0).
全自动核酸扩增分析仪由加热系统，光路系统，检测系统，主控显示系统，打印机系统，电源系统，随机软件（发布版本V1.0）组成。