(as of Sep 30,2022 17:59:16 UTC – Details)
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.
Product Dimensions : 6.18 x 3.19 x 0.71 inches; 1.98 Ounces
Date First Available : November 7, 2021
Manufacturer : iHealth
ASIN : B09L5BG137
Pack of 90 kits.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.
Expiration Date Extension: On July 8, 2022, the FDA granted another three-month shelf-life extension for the iHealth COVID-19 Antigen Rapid Test, which extended the shelf-life of all iHealth tests from 6 months to 12 months. Please refer to the FDA website for the detailed list of extended expiration dates by lot numbers: https://www.fda.gov/media/158007/download
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.