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Home » Business, Policy & Funding » Regulatory News & FDA Approvals » Thermo Fisher Scientific COVID-19 Test Receives CE Mark, Expanded FDA EUA

Thermo Fisher Scientific COVID-19 Test Receives CE Mark, Expanded FDA EUA

Mar 26, 2020
|
staff reporter

NEW YORK – Thermo Fisher Scientific said on Thursday that it has received the CE mark for its COVID-19 diagnostic test.

The test, which uses an Applied Bioystems TaqPath assay and real-time PCR technology, detects nucleic acid from SARS-CoV-2, the virus that causes COVID-19. It provides patient results within four hours of a sample being received by a lab, which include sample prep and analysis.

With the CE mark, the test is now available to qualified laboratories in the European Union and other countries in the European Economic Area.

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