COVID-19: FDA’s Stenzel Talks Abbott Test, Future Clearances In Call

Timothy Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health within the US agency's device center, offered an update on a controversial Abbott test and covered other issues during a COVID-19 developer webinar.

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People who test negative for COVID-19 using Abbott’s ID Now point-of-care test may need to confirm the result with a second test, a US Food and Drug Administration official said during a 20 May webinar.

The webinar was the ninth the FDA has hosted to update industry on the regulation and development of diagnostics for the novel coronavirus. Last week, the agency issued a public...

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