Before initiating the test, it is important to first read and closely follow the detailed instructions included in the package. The BinaxNOW TM 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.
Learn how to use the BinaxNOW TM COVID-19 Antigen Self Test.
Please use MakeMyTestCount to report your test result to public health agencies.
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.
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.
No Search Results Found.
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 |
|---|
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)
*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
Sign up to receive valuable updates from Abbott.
A Leader In Rapid Point-of-care Diagnostics.
©2024 Abbott. All rights reserved. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.
This website is governed by applicable U.S. laws and governmental regulations. The products and information contained herewith may not be accessible in all countries, and Abbott takes no responsibility for such information which may not comply with local country legal process, regulation, registration and usage.
Your use of this website and the information contained herein is subject to our Website Terms and Conditions and Privacy Policy. Photos displayed are for illustrative purposes only. Any person depicted in such photographs is a model. GDPR Statement
Not all products are available in all regions. Check with your local representative for availability in specific markets. For in vitro diagnostic use only. For i-STAT test cartridge information and intended use, refer to individual product pages or the cartridge information (CTI/IFU) in the i-STAT Support area.
Abbott - A Leader in Rapid Point-of-Care Diagnostics.
