Siemens Healthineers gets EUA from FDA for Covid-19 antigen self-test

ORIGINAL SOURCE: Medical Device Network
– CLINITEST Rapid COVID-19 Antigen Self-Test offers results in 15 minutes –

The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Siemens Healthineers for CLINITEST Rapid COVID-19 Antigen Self-Test.

The receipt of EUA will enable Siemens Healthineers to make the at-home or over-the-counter self-test available countrywide from January.

Claimed to be easy to use, this nasal swab test helps in the quick detection of SARS-CoV-2 and offers test results in 15 minutes.

The CLINITEST Rapid COVID-19 Antigen Self-Test has been authorised for self-testing use by people from the age of 14 years and above or adult-collected samples from individuals between the age of two and 13 years.

Siemens Healthineers stated that it has secured the production capacity for the test kit in the tens of millions in a month.