Dec 29, 2021 - Health

FDA authorizes Siemens Healthineers' at-home COVID test

 A stack of Covid-19 rapid tests "Clinitest Rapid COVID-19 Antigen Test" from Siemens Healthineers lie in the classroom at Lessing-Gymnasium in Wedding-Berlin.

A stack of COVID-19 rapid tests from Siemens Healthineers. Photo: Fabian Sommer/picture alliance via Getty Images

The Biden administration announced Wednesday that the FDA issued an emergency use authorization for an at-home COVID-19 test distributed by German company Siemens Healthineers.

Why it matters: Companies including Walmart, Walgreens Boots Alliance and CVS Health have this month put limits on the number of at-home COVID-19 testing kits customers can buy as the Omicron and Delta variant surge across the U.S., per Reuters.

The big picture: Siemens Healthineers' Clinitest rapid COVID-19 antigen self-test is authorized for use by anyone over 14 years of age or adult-collected samples from those age 2 to 13 years, per a company statement. It's expected to be available beginning in January.

  • The approval comes less than a week after Roche announced the Food and Drug Administration had authorized its COVID-19 at-home rapid test for those over 14.
  • The Department of Health and Human Services confirmed the approval of the Siemens Healthineers and Roche's tests in a statement Wednesday.

What's next: The Biden administration plans to purchase 500 million rapid tests to deliver to homes for free starting in January.

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