FDA authorized iHealth COVID-19 test for home use. Quick results in 15 mins with easy nasal swab. No discomfort. 2 tests in 1 pack.

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The iHealth COVID-19 Antigen Rapid Test is a package containing 2 tests that have been authorized by the FDA for at-home use. This test provides results within 15 minutes and involves a non-invasive nasal swab, which is easy to use and causes no discomfort.

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Introducing the FDA Authorized 15-Minute Self-Test from iHealth, a revolutionary at-home testing solution designed to detect the presence of COVID-19. Please note that this product has not been FDA cleared or approved, but it has been authorized by the FDA under an Emergency Use Authorization (EUA). Its authorization is specific to the detection of proteins from the SARS-CoV-2 virus and not for any other viruses or pathogens.

In these unprecedented times, it is crucial to have access to accurate and convenient testing methods. The iHealth 15-Minute Self-Test offers just that, providing individuals with the ability to test themselves for COVID-19 in the comfort of their own homes, without the need to ship their samples to a laboratory.

One of the key advantages of this self-test is its ease of use. With simple instructions and an intuitive design, anyone can perform the test with zero discomfort. All it takes is inserting a simple non-invasive nasal swab approximately 1/2 to 3/4 inch into the nostril. To ensure a smooth testing experience, step-by-step instructional videos are available in our optional iHealth Test app.

This self-administered test is recommended for individuals aged 15 years and older. However, for children between the ages of 2 and 14, adult-collection is required. This ensures accurate and reliable results for individuals of all ages.

In addition to its individual testing capabilities, the iHealth Test app also allows for efficient management of group testing. Whether it’s a school, workplace, or event, the app enables the administrator to monitor and track the test results of group members. This feature provides peace of mind and helps in implementing effective measures to prevent the spread of COVID-19.

The iHealth 15-Minute Self-Test is FDA authorized for emergency use under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1). It is important to note that the emergency use authorization is only valid as long as the declaration justifying its authorization is in effect. This means that the use of this test is authorized only for the duration of the current circumstances surrounding the COVID-19 pandemic, unless the declaration is terminated or the authorization is revoked sooner.

When it comes to product specifications, the iHealth 15-Minute Self-Test is not discontinued by the manufacturer. It has compact dimensions of 3.46 x 0.71 x 0.16 inches and weighs a mere 0.1 ounces. The item model number is ICO-3000, and it was first made available on November 4, 2021. The manufacturer of this product is iHealth, a trusted name in healthcare technology. The ASIN is B09KZ6TBNY, and the product originates from China.

In conclusion, the iHealth FDA Authorized 15-Minute Self-Test is a reliable and convenient solution for COVID-19 testing. With its ease of use, zero discomfort, and ability to manage group testing, it provides individuals and administrators with the necessary tools to stay informed and take appropriate actions in the ongoing fight against the pandemic. Please note the specific limitations and authorization details mentioned above to ensure the proper use of this product.

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