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www.fdanews.com/articles/198046-biosewooms-covid-19-test-gets-emergency-use-authorization

BioSewoom’s COVID-19 Test Gets Emergency Use Authorization

July 14, 2020

South Korean devicemaker BioSewoom has received an Emergency Use Authorization (EUA) from the FDA for its Real-Q COVID-19 detection kit.

The kit detects nucleic acid from the coronavirus from nasal or throat swabs, sputum, or bronchial specimens.

The test is only authorized for the duration of the COVID-19 pandemic and the labeling must state that the test “has not been FDA approved or cleared,” the agency said.

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