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Home » FDA extends shelf life of some popular COVID tests

FDA extends shelf life of some popular COVID tests

January 19, 2023 By Sean Whooley

Abbott BinaxNow antigen home self test covid-19
[Image courtesy of Abbott]
The FDA announced today that certain COVID-19 diagnostic tests under emergency use authorization now have a longer shelf life.

Diagnostics made by Abbott, Maxim Biomedical and iHealth Labs all received extensions for their expiration dates.

The Abbott BinaxNow COVID-19 antigen self-tests now have a shelf life of 22 months. Previously, the popular test had a 15-month shelf life.

Maxim Biomedical’s ClearDetect COVID-19 antigen home test initially received authorization with an eight-month shelf life. The FDA announced that it extended the shelf life of that test to 12 months.

iHealth Labs COVID-19 antigen rapid tests received a three-month extension from 12 months to 15 months.

“The expiration dates for these tests have been extended to reflect the longer shelf-life,” the FDA said in a notice. The agency based its extension on additional data provided by the manufacturers. This data demonstrated the tests’ durability with the same expected accuracy.

Filed Under: Diagnostics, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, News Well, Regulatory/Compliance Tagged With: Abbott, coronavirus, COVID-19, iHealth, Maxim Biomedical

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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