§ 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. This video details the test procedures for the BinaxNOW COVID-19 Ag Card tests including the supplies used, collection method required, and instructions for. 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. BinaxNOW ANTIGEN SELF TEST COVID-19 Instructions INTENDED USE The BinaxNOW. Any extended exposure of the test kit to temperatures beyond this range may affect quality of test results. The Abbott BinaxNOW rapid antigen test is cheaper and faster than real-time. This test has been authorized by the Food and Drug Administration (FDA) under an Emergency Use. 1 ABBOTT BinaxNOW Covid-19 Antigen Test Instructions 2 PROCEDURE CARD 2.1 Part 1 Sample Test Procedure 2.1.1 Patient Samples require 6 drops of Extraction Reagent 2.2 Part 2 Result Interpretation 2.2.1 Negative Result 2.2.2 Positive Result 2.2.3 Invalid Result 2.3 Procedure for External Quality Control Testing 2. 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☏). Instructions for Abbotts BinaxNOW COVID-19 Ag At-Home Test. BinaxNow At-Home Covid-19 Testing Kit Tutorial Philadelphia Department of Public Health 2. Please consult your medical provider for any other symptoms that are severe or concerning. This list of symptoms is not all inclusive. 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). The test does not replace the advice of a healthcare provider.
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