§ 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. 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.This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens. Abbotts widely used BinaxNow COVID test kits now have a shelf life of up to 22 months, depending on when the tests were manufactured.closing the digital healthcare divide that separates us. more of the latest in diagnostics testing. This test is also authorized for use at Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. to find a binaxnow covid-19 self test in your area, click here.§263a, to perform moderate, high or waived complexity tests.
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Additional online resources: - PDF Instructions (English) - PDF Instructions (Spanish) - Video. Instructions to perform the test are included inside your test kit box. This product has been authorized by FDA under an EUA for use by laboratories certified under the Clinical Laboratory Improvement of 14 Amendments of 1988 (CLIA), 42 U.S.C. The BinaxNOW COVID-19 Antigen Self Test will take about 20 minutes to complete.This test does NOT meet the CDC testing requirements to enter the U.S.
BinaxNOW COVID-19 Antigen Self Test is available under FDA Emergency Use Authorization. Details Antigen Self Test, Covid-19 A rapid test for the qualitative detection of Covid-19 antigens in nasal swab specimens. This product has not been FDA cleared or approved. Purchase the BinaxNOW COVID-19 Antigen Self Test and perform the test with a simple nasal swab in the comfort and convenience of your home.Infection Control Educational Resources.Supply Chain Best Practices During The Pandemic.InControl - Infection Prevention Products.InControl - Infection Prevention Information.Enjoy fast, FREE shipping on most orders.
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