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Abbott Nabs FDA Emergency Use Authorization for SARS-CoV-2 Test on High-Throughput System

NEW YORK – Abbott announced Tuesday the US Food and Drug Administration granted Emergency Use Authorization to the company's RealTime SARS-CoV-2 test for use with the Alinity m platform. 

The PCR-based test was previously authorized in March for use with the firm's m2000 RealTime system.

The Abbott Park, Illinois-based company said its Alinity m system was cleared by the agency for use with Abbott's hepatitis C assay in March and is in the process of being fully commercially launched for customers in the US. The automated system can run up to 1,080 tests in 24 hours, while the m2000 RealTime system can run up to 480 tests in 24 hours, the firm said. 

Abbott has also received EUA for its point-of-care SARS-CoV-2 test and its serology test for use on the Architect systems and the Alinity i platform. 

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