The iHealth® COVID-19 Rapid Antigen Test is a lateral flow assay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. The test can be completed in the comfort of your own home in 15 minutes without the need to ship your sample to a lab.
Manage large group testing with the 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.
Product Specifications
Tests/Box
2
Sample type
Anterior nares swab (minimal discomfort swab)
Time to results
15 minutes
Detection
Current and new COVID-19 variants
Age Limit
2 years old and above
Group testing
Managed via mobile app
Certification
FDA EUA
Additional Information
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. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
