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  • COVID-19: Endemic Disease
  • Products
    • ASSURE-100 Home Tests
    • ASSURE-100 POC Tests
    • Buy ASSURE-100 Tests
  • News & Updates
  • Contact Us
  • BUY TESTS
Understanding the FDA’s Role in COVID-19 Rapid Tests and Vaccines

Understanding the FDA’s Role in COVID-19 Rapid Tests and Vaccines

by Oceanit | Jan 16, 2025 | General, Government

Understanding the FDA’s Role in COVID-19 Rapid Tests and Vaccines The Food and Drug Administration (FDA) has played a critical role in the fight against COVID-19. From evaluating the safety and efficacy of vaccines to authorizing rapid testing methods, the agency has...
Understanding FDA Emergency Use Authorizations During COVID-19

Understanding FDA Emergency Use Authorizations During COVID-19

by Oceanit | Dec 18, 2024 | General, Government

Understanding FDA Emergency Use Authorizations During COVID-19 How Do FDA Emergency Use Authorizations Work? The COVID-19 pandemic introduced many Americans to the term “Emergency Use Authorization” (EUA). This critical regulatory mechanism, issued by the U.S. Food...

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Copyright 2025 Oceanit Foundry LLC. The ASSURE-100 Rapid COVID-19 Test has not been FDA cleared or approved, but has been authorized by FDA under an EUA. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of 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. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
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