NYSDA Publications

FDA Authorizes First COVID-19 Diagnostic Test That Uses Breath Samples

The United States Food and Drug Administration (FDA) has authorized the first novel coronavirus (COVID-19) diagnostic test that uses breath samples.  FDA notes that the test can be performed in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals, and mobile testing sites, using an instrument about the size of a piece of carry-on luggage, and can provide results in less than three minutes.  To read the FDA announcement and summary of its authorization of the first COVID-19 diagnostic test that uses breath samples, use the first link below.  To read the complete FDA authorization for the first COVID-19 diagnostic test that uses breath samples, use the second link below.
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-diagnostic-test-using-breath-samples?utm_medium=email&utm_source=govdelivery  (FDA announcement and summary of authorization for COVID-19 breath test)
https://www.fda.gov/media/157720/download?utm_medium=email&utm_source=govdelivery  (FDA complete authorization for COVID-19 breath test)
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