On December 22, 2022, Oceanit’s ASSURE-100 received FDA Over-The-Counter authorization. The ASSURE-100 Rapid COVID-19 Home Test authorization, an over-the-counter home test, comes ten months after initial point-of-care EUA was granted on February 28, 2022.
All posts tagged: ASSURE-100
ASSURE In the News
Hawaii News Now | Hawaii-Made Rapid COVID Test Gets Emergency FDA Approval
Hawaii News Now visited Oceanit office to interview the ASSURE team about the recent US FDA Emergency Use Authorization for the ASSURE-100 Rapid COVID-19 test
KITV4 | Oceanit Gets Emergency Clearance for Rapid COVID-19 Tests
KITV4 Island News visited Oceanit’s offices and labs yesterday to speak with Oceanit CEO, Dr. Patrick Sullivan about the newly authorized ASSURE-100 Rapid COVID-19 Test.
HPR | FDA Approves Emergency Use for First Rapid COVID-19 Test Developed in Hawaiʻi
Oceanit CEO, Dr. Patrick Sullivan joined Hawaii Public Radio host, Catherine Cruz to discuss the ASSURE-100 Rapid COVID-19 Test. Their ten minute discussion covered the research & development that went into ASSURE-100, the FDA EUA process, and what comes next.
PRESS RELEASE | Oceanit Receives FDA Emergency Use Authorization for ASSURE-100 Rapid COVID-19 Tests
Oceanit receives U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the ASSURE-100 rapid antigen test for detection of COVID-19.