Until now, all PCR diagnostics have required an expensive instrument, specially trained personnel, and sending samples to a centralized lab. Our product changes all that and provides test results in minutes, instead of days.
Visby Medical COVID-19 test has not been FDA cleared or approved; it has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The Visby Medical COVID-19 test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.