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That is correct. From the FDA Emergency Use Authorization: "Your product is an automated assay that utilizes isothermal nucleic acid amplification technology f
by rediguanayum 5y ago
That is correct. From the FDA Emergency Use Authorization: "Your product is an automated assay that utilizes isothermal nucleic acid amplification technology for the qualitative detection of SARS-CoV-2 viral nucleic acids." Also interesting: "Heating, mixing, amplification, and detection take place within the cartridge. The current flow from the electrodes is converted to a positive or negative result (based on a pre-determined cutoff)." https://www.fda.gov/media/146467/download https://www.fda.gov/media/146467/download