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22 Nov iBar

Posted at 08:50h in by opet

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NOTICE

This device should not be solely or primarily relied upon to diagnose or exclude a diagnosis of COVID-19, or any other disease. Elevated body temperature in the context of use should be confirmed with secondary evaluation methods (e.g., an NCIT or clinical grade contact thermometer). Public health officials, through their experience with the device in the particular environment of use, should determine the significance of any fever or elevated temperature based on the skin telethermographic temperature measurement. The technology should be used to measure only one subject’s temperature at a time. RapidScreen is not a medical device nor is it FDA approved. Visible thermal patterns are only intended for locating the points from which to extract the thermal measurement. Product images and user interfaces shown on the site and marketing materials are for illustrative purposes only, may not represent specific capabilities or features and may differ from the actual product. For additional information, we recommend you review the terms and conditions and Privacy Policy.

Important Information

The COVID-19 Antigen Rapid Test Cassette has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by laboratories operating minimally with a CLIA Certificate of Waiver. This test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. This test 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.