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

 
• By Elizabeth Orr

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.

FDA entrance sign 2016

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 alert warning that the Abbott test posed a risk of false negatives

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UK Medtech Regulators Must Ensure Certainty So Businesses Can Plan Their Futures

 
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