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binax covid test shelf lie extended

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Binax tests now have a 15 month shelf life 3 months longer than printed on the box

  January 7, 2022
Angela Drysdale
VP, Regulatory Affairs
Abbott Diagnostics Scarborough, Inc.
10 Southgate Road
Scarborough, ME 04074
Re: EUA203107/S003
Trade/Device Name: BinaxNOW COVID-19 Ag Card Home Test
Dated: December 8, 2021
Received: December 9, 2021
Dear Ms. Drysdale:
This is to notify you that your request to update the shelf-life expiration date of the BinaxNOW COVID-19 Ag Card Home Test to 15 months at room temperature (28–30°C) based on the results of your ongoing stability studies is granted. Upon review, we concur that the data and information submitted in EUA203107/S003 supports the
requested updates for use with the BinaxNOW COVID-19 Ag Card Home Test.

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