普门科技取得一项医疗器械注册证

Core Viewpoint - The company has received a medical device registration certificate from the Guangdong Provincial Drug Administration for its new fully automated chemiluminescence immunoassay analyzers, the eCL8600 and eCL8800 series, which utilize a novel electrochemiluminescence immunoassay technology based on tris(2,2'-bipyridyl)ruthenium [1] Group 1 - The eCL8600 series has a testing speed of 200 tests per hour, while the eCL8800 series can perform 260 tests per hour [1] - The devices support batch testing with intelligent scheduling and prioritize specified sample tubes for testing, providing initial results in as little as 9 minutes [1] - The analyzers allow for continuous operation by enabling the replacement of consumables without stopping the device, enhancing operational efficiency [1] Group 2 - The use of biomimetic mixing technology improves mixing efficiency, which contributes to increased testing efficiency and convenience for end hospitals [1]