Home » BioSewoom’s COVID-19 Test Gets Emergency Use Authorization
BioSewoom’s COVID-19 Test Gets Emergency Use Authorization
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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