Global Point of Care
Before initiating the test, it is important to first read and closely follow the detailed instructions included in the package. The BinaxNOWTM COVID-19 Antigen Self Test has received U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA).*
Only available in the US. Terms of Sale.
Please use MakeMyTestCount to report your test result to public health agencies.
Capture your results in NAVICA for self‑reporting.
Capture your results in NAVICA for self‑reporting.
Find a test kit at your local retailer.
Complete your test, or help others administer if they require assistance.
Wait 15 minutes and view the results.
Follow the Instructions for Use regarding serial, or repeat, testing.
Capture your results in NAVICA for
self‑reporting.
Find a test kit (contains 2 tests) at your local retailer.
Complete your test, or help others administer if they require assistance.
Wait 15 minutes and view the results.
Follow the Instructions for Use regarding serial, or repeat, testing.
Since the launch of the BinaxNOW™ COVID-19 Antigen Self Test, Abbott has continued testing for product stability to extend the expiration date and have shared these results with the FDA. Testing has been completed to support a shelf-life (expiration date) of up to 22 months. The BinaxNOW™ COVID-19 Antigen Self Test, part number 195-160 or 195- 180, may now have a longer than labeled product expiry date. All BinaxNOW COVID-19 Antigen Self Test kits currently have a twenty-two-month expiry date.
| KIT LOT NUMBER | ORIGINAL PRINTED EXPIRATION DATE^ | EXTENDED EXPIRATION DATE |
|---|
Expiration date extension information for other self-test brands can be found at the FDA website:
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests
Disclaimer:
This tool is designed to offer a convenient way for consumers to lookup extended dating by lot number, utilizing information shared by Abbott with the FDA. For official information, please see the FDA letter listing BinaxNOW™ COVID-19 Antigen Self Test kit lot numbers, currently labeled kit expiry and new kit expiry date available on the FDA website at https://www.fda.gov/media/158003/download.
Note: do not use LOT number on individual kit components (test cards, nasal swabs, reagent bottles, instructions, or fact sheet)
Learn how to use the BinaxNOW COVID-19 Antigen Self Test.
Learn how to use the BinaxNOW COVID-19 Antigen Self Test and store your results in the NAVICA app for self-testing.
*The BinaxNOW™ COVID-19 Antigen Self Test has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization. It has been authorized only for the detection of proteins from SARSCoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
^Some kits may have an additional label added that states “New expiry date. Disregard dates printed on components.” Original printed expiration date may be covered by this new label.
1. FDA Letter: Revisions Related to Serial (Repeat) Testing for the EUAs of Antigen IVDs. November 1, 2022. Accessed January 26, 2023. https://www.fda.gov/media/162799/download
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