- This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA;
product has been authorized only for the detection of proteins from
SARS- CoV-2, not for any other viruses or pathogens; and,
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. § 360bbb-3(b)(1), unless the declaration is terminated
or authorization is revoked sooner.
Disclaimer: If you’re currently experiencing COVID-19 symptoms, please contact your primary care physician (PCP) for immediate guidance. This is not a
PCR test and not valid for travel. The manufacturer of the iHealth®
COVID-19 Antigen Rapid Test requires test kits be stored at temperatures
between 36o and 86oF (2o - 30oC).
Any extended exposure of the test kit to temperatures beyond this range
may affect quality of test results. If you have ordered home delivery
of the test kit and expect temperatures in your area to be outside of
this range at time of delivery, it is recommended that you arrange for
someone to be home at or near time of delivery to receive the test kit.