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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
PRESS RELEASE | ASSURE-19 Begins Clinical Testing to Acquire FDA Emergency Use Authorization

PRESS RELEASE | ASSURE-19 Begins Clinical Testing to Acquire FDA Emergency Use Authorization

by Oceanit | Aug 25, 2020 | General

PRESS RELEASE | ASSURE-19 Begins Clinical Testing to Acquire FDA Emergency Use Authorization Oceanit and the Queen’s Medical Center have started patient trials with ASSURE-19 rapid point-of-need Covid-19 tests as of Saturday, August 22. Oceanit is collaborating with...
ASSURE-19 Featured on Hawaii News Now, Honolulu Star Advertiser, and Pacific Business News

ASSURE-19 Featured on Hawaii News Now, Honolulu Star Advertiser, and Pacific Business News

by Oceanit | Aug 21, 2020 | Future, Local News

ASSURE-19 Featured on Hawaii News Now, Honolulu Star Advertiser, and Pacific Business News With the recent announcement of continued support from the National Institutes of Health RADx initiative, Oceanit’s ASSURE-19 rapid point-of-need COVID-19 test progress was...
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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