www.fdanews.com/articles/200985-mirxes-earns-ce-mark-for-covid-19flu-test
MiRXES Earns CE Mark for COVID-19/Flu Test
January 22, 2021
Singapore-based MiRXES’ Fortitude SARS-CoV-2/influenza test kit has received a CE mark in Europe and regulatory clearance in Singapore.
The multiplex test combines a reverse transcription polymerase chain reaction (RT-PCR) COVID-19 test kit with assays for influenza A and B, and can distinguish between SARS-CoV-2 viruses and flu pathogens.
The company said it is currently seeking Emergency Use Authorization from the FDA and approval from Japan’s Pharmaceuticals and Medical Devices Agency for the test.