Extended Expiration Dates: Access Bio and OSANG COVID-19 Tests

U.S. Food and Drug Administration sent this bulletin at 09/01/2022 03:28 PM EDT

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Center for Devices and Radiological Health

Update: Extended Expiration Dates for Access Bio and OSANG COVID-19 Tests

Access Bio, Inc. CareStart COVID-19 Antigen Home Tests and OSANG LLC OHC COVID-19 Self Tests packaging

Access Bio, Inc. CareStart COVID-19 Antigen Home Tests and OSANG LLC OHC COVID-19 Self Tests that are FDA authorized under emergency use authorization now have a longer shelf-life than previously authorized. The expiration dates for these tests have been extended to reflect the longer shelf-life. The extension is based on additional data provided by the manufacturer showing how long the test can be used with the same expected accuracy.

Check whether your Access Bio, Inc. CareStart COVID-19 Antigen Home Test, OSANG LLC OHC COVID-19 Self Test, or another test that you have 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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