When it comes to testing for COVID-19, your patients are looking for answers —  and you're looking for a fast, easy and cost-effective way to help. Abbott has designed the BinaxNOW™ COVID-19 Ag Card for decentralized testing, so you can test right at the point of care and get results for your patients quickly and easily.

The BinaxNOW COVID-19 Ag Card test has received U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA).* 

Only available in the US.

BinaxNow-Covid-19 Ag Card BinaxNow-Covid-19 Ag Card BinaxNow-Covid-19 Ag Card


*The BinaxNOW COVID-19 Ag Card 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 SARS-CoV-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.

** Before testing patients, federal regulations require testing sites to have a CLIA certificate issued by CMS. Sites performing only waived tests must obtain a Certificate of Waiver by applying for this certification for each location performing testing. Learn more about CLIA

***Refer to the product package insert for full instructions, clinical data and information on serial testing. 

  1. FDA Letter "Revisions Related to Serial (Repeat) Testing for the EUAs of Antigen IVDs." November 1, 2022. Accessed March 3, 2023.

©2023 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 | Declaration for California Compliance Law.

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.