IHealth Covid-19 Antigen Rapid Test (2 TESTS PER BOX, OTC)
New variants have shown that anyone can be vulnerable to COVID-19 even if they are vaccinated or young. With iHealth COVID-19 Antigen Rapid Test, you can test yourself after being out in public. Early and regular testing helps you better care for yourself and protects your friends, family, and community members from potential exposure.
FDA Authorized 15-Minute Self-Test: The test is a 15-minute self-test to detect whether or not an individual has COVID-19. The test can be completed in the comfort of your own home without the need to ship your sample to a lab.
The iHealth COVID-19 Antigen Rapid Test is a lateral flow assay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.
Easy to Use with Zero Discomfort: Test can be done by inserting 1/2 to 3/4 inch of a simple non-invasive nasal swab. Step-by-step instructional videos are available in our app (Installation of app is optional).
For Ages 2 and Above : The self-administered test is recommended for individuals aged 15 years and older. Adult-collection is required for testing children 2-14 years old.
Manage Group Testing Via Mobile App: The iHealth Test app allows the administrator of a small group to monitor and track the group members’ test results as needed at school, work or an event.
Below is the link to the FDA EUA for IHealth
https://www.fda.gov/media/153925/download
Below is the link to the FDA IFU for IHealth
Below is a link to the iHealth COVID-19 Antigen Rapid Test - Healthcare Provider Fact Sheet
https://www.fda.gov/media/153922/download
Disclaimer:
• 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 SARSCoV-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.
