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

SUNNYVALE, Calif., Oct. 26, 2021 /PRNewswire/ — 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 a cloud-based software that is seamlessly connected to the Internet and enables cloud data storage and retrieval – another key requirement for 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."

About Anitoa
Anitoa Systems, a medical device technology start-up established in 2013 with headquarter in Sunnyvale, California, develops highly integrated and low-power CMOS-based bio-sensor devices for fluorescence and chemiluminescence-based molecular imaging. By replacing the traditional bulky and costly photon-multiplier tube (PMT) and CCD-based optical sub-systems, Anitoa’s ultra-low-light CMOS sensor technology enables a new generation of compact and inexpensive molecular testing platforms targeting infectious, oncology and cardio-vascular markers. Anitoa manufactures its qPCR instruments in Hangzhou, China and Fremont, California, USA. For further information please contact: Sales & PR Contact: Li Liu, Anitoa Systems, LLC, or 408-887-6026.

SOURCE Anitoa Systems, LLC