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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
IN THE NEWS | Oceanit Progresses Towards FDA EUA Submission

IN THE NEWS | Oceanit Progresses Towards FDA EUA Submission

by Oceanit | Dec 28, 2020 | Local News

IN THE NEWS | Oceanit Progresses Towards FDA EUA Submission Oceanit has been hard at work to develop and perfect the ASSURE-19 rapid test for submission to the U.S. FDA for emergency use authorization. Hawaii News Now reconnected with Dr. Patrick Sullivan last week to...
COVID-19 Cases Still Growing, Links to Academic Papers

COVID-19 Cases Still Growing, Links to Academic Papers

by Oceanit | Nov 6, 2020 | General, National News

COVID-19 Cases Still Growing, Links to Academic Papers On October 24th, the United States tracked 78,702 new infections of Covid-19, a +32% 14-day change. The same day, 871 new COVID-related deaths were counted, this represents a +15% 14-day change.  According to the...
Press Release | AUG 20: NIH Funding and Moving to Trials

Press Release | AUG 20: NIH Funding and Moving to Trials

by Oceanit | Aug 19, 2020 | Government, Local News, National News

Press Release | AUG 20: NIH Funding and Moving to Trials Honolulu, HI | AUG 20th – Oceanit’s ASSURE-19 test kit awarded NIH RADx funding, set to begin clinical trials. Oceanit Laboratories’ ASSURE-19 rapid point-of-need COVID-19 test has been selected for...

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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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