emergency use authorization
The agency is cross-training employees to add surge capacity in response to shifting demand and is helping develop a pending national testing plan.
BioTeke Nabs FDA EUA for COVID-19 Rapid Antigen Test
The Bio-Self COVID-19 Antigen Home Test is a lateral flow immunoassay that uses nasal swab samples and delivers results in 15 minutes.
FDA Grants Emergency Use Authorization for Nano-Ditech OTC COVID-19 Antigen Test
Nano-Ditech, a subsidiary of South Korea's Precision Biosensor, previously received EUA from the FDA for a prescription version of the test.
FDA Issues EUAs for COVID Molecular Tests From Access Medical, Drexel University
Both tests are RT-PCR-based. Access Medical's test uses nasopharyngeal and anterior nasal swab specimens, while Drexel's uses mid-turbinate nasal swab specimens.
FDA Grants Emergency Use Authorization for Princeton BioMeditech At-Home COVID-19 Antigen Test
The company had previously received funding through the US National Institutes of Health's Rapid Acceleration of Diagnostics initiative to develop a rapid COVID-19 test.