CLINITEST® Rapid COVID-19 Antigen Self-Test
FDA EUA Authorized OTC at-Home Rapid Antigen Self-Test Kit: The CLINITEST Rapid COVID-19 Antigen Self-Test is intended to aid in the rapid detection of SARS-CoV-2 (the virus that causes COVID-19) and provides accurate results in just 15 minutes.
Easy-to-use, Easy-to-read: No special training or equipment required. All it takes is a quick and gentle nasal swab to collect the sample, drop onto the visually-read test cassette, and interpret the results. Step-by-step instructional video is available online, along with downloadable Instructions for Use (IFU).
Accurate Results for Peace of Mind: Get the answers you need with a fast, reliable, and convenient at-home OTC COVID-19 self-test. Authorized for unsupervised self-testing use by individuals aged 14 and older (or adult-collected samples from individuals ages 2-13).
In the USA, this product has not been FDA-cleared or approved but has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. 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 availability may vary by country.
Distributed by Siemens Healthineers.
Please follow local government and health regulations and guidance with respect to COVID-19 health and safety.