(RTTNews) - Abbott has received Emergency Use Authorization from the U.S. Food and Drug Administration for Covid-19 antibody blood test on Alinity i System. It is the company's fourth Covid-19 test to receive the authorization, the company said in a statement.
The company plans to ship about 30 million antibody tests globally in May across its ARCHITECT and Alinity i platforms and will have capacity for 60 million tests in June.
Last month, Abbott received FDA EUA and CE Mark for its SARS-CoV-2 IgG antibody blood test on the ARCHITECT system. Abbott has already begun shipping antibody tests for use on the ARCHITECT systems globally including in the U.S., UK, Italy, Spain and India.
Abbott also expects to submit this week for CE Mark to the IVD Directive in the European Union for the Alinity i SARS-CoV-2 IgG test.
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