Product shelf life minimum: 2025
UPC: 856362005891
NDC: 56362-0005-90
The iHealth® COVID-19 Antigen Rapid Test functions as a lateral flow assay designed to qualitatively identify nucleocapsid protein antigen from SARS-CoV-2. This test holds authorization for at-home use without a prescription. It is intended for individuals aged 15 years or older who are experiencing symptoms of COVID-19 within the initial 7 days of symptom onset. It involves self-collection of anterior nasal (nares) swab samples.
In addition, this test also possesses authorization for at-home use without a prescription. It can be used by individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. In this case, adults collect the nasal swab samples.
Moreover, this test is authorized for at-home use without a prescription. It encompasses self-collection of anterior nasal (nares) swab samples from individuals aged 15 years or older, as well as adult-collected anterior nasal swab samples from individuals aged 2 years or older. The test is to be administered twice over a span of three days, with a minimum of 24 hours (and no more than 48 hours) between the two tests."
Steps. 15 Minutes. Zero Discomfort.
iHealth COVID-19 Antigen Rapid Test is an effortless way to detect SARS-CoV-2 nucleocapsid protein antigen. It only takes four 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.
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.
DETECT CURRENT AND NEW COVID VARIANTS
iHealth has completed in-lab testing on several heat inactivated variant strains and the results show that iHealth COVID-19 Antigen Rapid Test was able to detect the mutations of both the Delta and Omicron Variant.
- 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.
