![]() § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests 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. It has been authorized by the FDA under an emergency use authorization. The BinaxNOW™ COVID-19 Ag Card Home Test has not been FDA cleared or approved. If you have ordered home delivery of the test kit and expect temperatures in your area to be outside of this range at time of delivery, it is recommended that you arrange for someone to be home at or near time of delivery to receive the test kit. Any extended exposure of the test kit to temperatures beyond this range may affect quality of test results. The manufacturer of the BinaxNOW COVID-19 Ag Card Home Test Kit requires test kits be stored at temperatures between 2 and 30☌ (35.6 - 86☏). A simple solution for COVID-19 infection detection. Please consult your medical provider for any other symptoms that are severe or concerning. Abbott BinaxNOW COVID-19 Antigen Self-Test offers rapid results in the convenience of your home. Carefully read instructions prior to starting test. This list of symptoms is not all inclusive. The BinaxNOW COVID-19 Antigen Self Test is a lateral flow immunoassay intended. SIMPLE AND EASY TO USE: Requires just a shallow nasal swab that you can do yourself includes easy-to-follow instructions. ![]() Hovering 1/2 inch above the TOP HOLE, slowly add 6 DROPS to the TOP HOLE of. Collect the nasal sample, or help administer if they require. Procedure for Patient Specimens Hold Extraction Reagent bottle vertically. If the person being tested is age 17 or younger). You should seek immediate medical attention if you or your family members demonstrate emergency warning signs of COVID-19 (trouble breathing, bluish lips or face, or severe and constant pain or pressure in the chest). Abbott BinaxNOW COVID-19 Self Test Kit - (2 Tests) 2 Tests per package 1. Open the NAVICA app on your smartphone/tablet and Create a NAVICA account with a username and password. The test does not replace the advice of a healthcare provider. Use the instructions to see the letter and listing of BinaxNOW COVID-19 Ag Card lots which qualify for this expiry extension.
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