US FDA Approves Siemen Healthineer Home Testing Kit

The US FDA has approved the Emergency Use Authorization For Siemens Healthineers’ CLINITEST® Rapid COVID-19 Antigen Self-Test.

“CLINITEST Rapid COVID-19 Antigen Self-Test has been granted FDA Emergency Use Authorization,” said Siemens Healthineers.

The CLINITEST Rapid COVID-19 Antigen Self-Test is used for unsupervised self-testing for the SARS-CoV-2 virus by individuals age 14 and older or collected by adults for younger children. 

“The CLINITEST Rapid COVID-19 Antigen Self-Test detects SARS-CoV-2 antigens in people who are actively infected with the virus, making important information more readily available,” said Christoph Pedain, PhD, Head of Point of Care Diagnostics, Siemens Healthineers.

The kit will reportedly be able to give test results within 15 minutes and will be available starting in January. 

According to Pedain, the CLINITEST Rapid COVID-19 Antigen Self-Tes will provide access to a fast, reliable, and convenient test as coronavirus cases continue to rise in the United States.


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