§ 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. Hovering 1/2 inch above the TOP HOLE, slowly add 6 DROPS to the TOP HOLE of. PRINCIPLES of the PROCEDURE The BinaxNOW COVID-19 Antigen Self Test is an immunochromatographic membrane assay that uses highly sensitive antibodies to detect SARS-CoV-2 nucleocapsid protein from direct anterior nasal swab specimens. 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. Procedure for Patient Specimens Hold Extraction Reagent bottle vertically. 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☏). BinaxNOW ANTIGEN SELF TEST COVID-19 Instructions INTENDED USE The BinaxNOW. Please consult your medical provider for any other symptoms that are severe or concerning. The Abbott BinaxNOW rapid antigen test is cheaper and faster than real-time. 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). Phelan announced the formation of a House. It might help the push for school vouchers. The BinaxNOW COVID-19 Antigen Self Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 infection when tested twice over three days with at least 36 hours between tests. The test does not replace the advice of a healthcare provider. Greg Abbott and House Speaker Dade Phelan join forces on property taxes.
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