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MEDICAL DEVICE NEWS MAGAZINE

HomeFDA UpdatesAnitoa Receives FDA Registration and Class II Exempt Device Listing for its...

Anitoa Receives FDA Registration and Class II Exempt Device Listing for its Maverick Line of Portable qPCR Instruments

Anitoa Systems, LLC., a Silicon Valley biotechnology company and market leader in rapid, portable molecular testing hardware, today announced its Maverick line of qPCR instruments have received US FDA registration and device listing as class II 510(k) exempt medical device.

Due to their small size, ease of use, and fast time to result, Anitoa’s Maverick line of qPCR devices have been adopted worldwide for rapid, on-site testing of infectious pathogens in human, food, and the environment. Since the outbreak of COVID-19 at the beginning of 2020, Maverick qPCR devices have been widely used around the world to test for COVID-19, achieving sample-to-results in less than 45 minutes with standard RT-PCR chemistry.

Available in 4, 8, and 16 well formats, Maverick qPCR instruments are packed with technology innovations from Anitoa. These include a unique proprietary low-light sensitive, complementary metal-oxide-semiconductor (CMOS) 4-channel fluorescence optics system that allows fast and highly multiplexed DNA detection without the need for field calibration, at much lower cost and footprint. Maverick is further enhanced with cloud-based software that is seamlessly connected to the Internet and enables cloud data storage and retrieval – another key requirement for the deployment of portable instruments.

“We are excited to offer laboratories throughout North America and other international markets a portable solution for rapid and on-site nucleic acid tests to help combat diseases such as COVID-19,” said Dr. Zhimin Ding, CEO of Anitoa Systems.” We believe our portable qPCR instruments and the software solutions offer features that meet the needs of customers seeking highly sensitive detection of key life-threatening pathogens while being extremely cost-effective.”