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Abbott Garners Emergency Use Authorization for SARS-CoV-2 Test

NEW YORK – Abbott announced after the close of the market on Wednesday that its molecular test for SARS-CoV-2 has received Emergency Use Authorization from the US Food and Drug Administration.

The Abbott RealTime SARS-CoV-2 EUA test runs on the company's PCR-based m2000 RealTime System. The company said it would work with health systems and government authorities to distribute additional instruments where needed. Right now, there are more than 175 PCR m2000 instruments in the US, each one able to run up to 470 tests in 24 hours. 

The company will immediately ship 150,000 Abbott RealTime SARS CoV-2 tests to its existing customers and it said tests have already been sent to hospital and academic medical center labs in 18 states. 

The Abbott Park, Illinois-based company also said it is scaling up production at its US manufacturing location to reach the capacity for 1 million tests per week by the end of the month. 

Assays for the coronavirus from Roche, Thermo Fisher Scientific, Hologic, Laboratory Corporation of America, and Quidel have also received EUA designation from the FDA during the past week. 

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