US FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19


U.S. FDA recently issued an emergency use authorization (EUA) of the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19 which does not require a doctor's prescription and does not require a laboratory to provide results. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample from the nose. The test is an antigen test which detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older. PCR Tests are considered more accurate than antigen tests, but overall the FDA found the device to be safe and effective sufficient for an EUA. 

For More information see source here: 

Thomas Regulatory Resolutions (TRR) is a lean medical device consulting firm serving the medical device industry by providing value-added consulting services to medical device manufacturers for FDA submissions, FDA Compliance 510(k), Establishment Registration, FDA US Agent, CE Marking per EU MDR 2017/745 and Clinical Evaluation Reports (CERs) per MEDDEV 2.7/1 among other regulatory services.

Count on us for all of your medical device regulatory submission needs.

You may contact us via phone at +1 561 898 0260 or email or if you are ready now to schedule a free 30 minute appointment with us, please do so here: and we are standing by to support your medical device regulatory and compliance needs.