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*THESE TESTS ARE AVAILABLE FOR SALE IN CANADA UNDER AN INTERIM ORDER COVID-19 AUTHORIZATION (IO). The Sofia SARS Antigen FIA and Sofia 2 Flu + SARS Antigen FIA have not been cleared or approved by the Canadian Ministry of Health but has been authorized by Health Canada under an Interim Order COVID-19 Authorization (IO). This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. This authorization is only valid for so long as the Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 is in effect, pursuant to the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, made by the Minister of Health on March 18, 2020.