The OnSite COVID-19 Ag Self Test is a single-use lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swab specimens from individuals suspected of COVID-19. The test is designed for use with self-collected samples within the first 7 days post-onset of symptoms, as an aid in identifying SARS-CoV-2 Ngày 12/12/2021, Bộ Y tế có quyết định cấp phép cho một loại test nhanh kháng nguyên SARS-CoV-2 là: - Trueline Covid-19 Ag Rapid Test do Công ty TNHH Medicon sản xuất, định tính phát hiện kháng nguyên SARS-CoV-2 trong mẫu ngoáy dịch tỵ hầu và dịch mũi. Intended for use as an additional, more specific test to confirm the presence of antibodies to HIV-1 and HIV-2 for specimens found to be repeatedly reactive by diagnostic screening procedures. The COVID-19 Ag Test ENG Please read the instruc ons carefully before use! Invalid If there is no colored line in the control region (C), the result is invalid. COVID-19 Ag COVID-19 Ag If no colored line appears in the test line (T) and a colored line is present on the control region (C), then the result is negative. March 29, 2023. All individuals whose specimens are tested with this product will receive the Fact Sheet for Patients for the product. This Fact Sheet informs you of the significant known and You are being given this Fact Sheet because your sample(s) was tested for the Coronavirus Disease 2019 (COVID-19) using the BinaxNOW COVID-19 Ag Card. This Fact Sheet contains information to help you understand the risks and benefits of using this test for the diagnosis of COVID-19. After reading this Fact Sheet, if you have questions or would The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the uncertified COVID-19 test kit: 1. “ICHROMA COVID-19 AG” 2. “HUMASIS COVID-19 AG TEST ONE STEP COVID-19 AG TEST” The FDA verified through post-marketing surveillance that the abovementioned COVID-19 test kits are You are being given this Fact Sheet because your sample(s) was tested for the Coronavirus Disease 2019 (COVID-19) using the LumiraDx SARS-CoV-2 Ag Test. This Fact Sheet contains information to help you understand the risks and benefits of using this test for the diagnosis of COVID-19. After reading this Fact Sheet, if you have questions or uWpM9fG.

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