Extended Expiration Date for Two OTC COVID-19 At-Home Tests

U.S. Food and Drug Administration sent this bulletin at 05/04/2023 11:20 AM EDT

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Center for Devices and Radiological Health

Update: Expiration Dates Extended for Two OTC COVID-19 At-Home Tests

Extended Expiration Dates - packaging for BinaxNOW COVID-19 Ag Card Home Test and Hotgen COVID-19 Antigen Home Test

The following OTC COVID-19 at-home tests now have longer shelf lives than previously authorized:

Hotgen COVID-19 Antigen Home Test (Beijing Hotgen Biotech Co., Ltd.)
BinaxNOW COVID-19 Ag Card Home Test (Abbott Diagnostics Scarborough, Inc.)

The expiration dates for these tests have been extended to reflect the longer shelf life. The extensions are based on additional data provided by the manufacturers showing how long the tests can be used with the same expected accuracy.

Check whether your OTC at-home COVID-19 test has a new expiration date.

Check Expiration Dates

Visit At-Home OTC COVID-19 Diagnostic Tests and At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions for more information.

Questions?

If you have questions about this update, contact the Division of Industry and Consumer Education.

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