iHealth COVID-19 Antigen Rapid Test
iHealth COVID-19 Antigen Rapid Test is the simplest way to detect SARS-CoV-2 nucleocapsid protein antigen. It only takes 4 steps and 15 minutes to complete the test. The test is also non-invasive. You won't need to collect a sample from deep in your nasal cavity to get accurate results.
An in-home test designed to get accurate results.
Not only is the iHealth COVID-19 Antigen Rapid Test easy and non-invasive, it’s a small engineering beauty. The test has a highly-absorbent swab that is individually sealed to help prevent contamination so you can view the results of your in-home test with confidence.
In the USA, this product has not been FDA cleared or approved; but has been authorized by FDA under an EUA;
This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and,
The emergency use of this product 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. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
For more information on EUAs please visit: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19