FDA Grants EUA for COVID-19 combo test kit

Feb. 17, 2021

Thermo Fisher Scientific announced that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the company’s Applied Biosystems TaqPath COVID-19, Flu A, Flu B Combo Kit, according to a news release from Thermo Fisher.

The TaqPath COVID-19, Flu A, Flu B Combo Kit is a real-time PCR test for the detection and differentiation of RNA from the SARS-CoV2, influenza A and influenza B viruses in nasopharyngeal and nasal swabs.

The TaqPath COVID-19, Flu A, Flu B Combo Kit includes Applied Biosystems Pathogen Interpretive Software to automatically convert genetic analysis data into a readable report, helping reduce risk of user interpretation error.

Testing with the TaqPath COVID-19, Flu A, Flu B Combo Kit is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity tests.

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