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www.fdanews.com/articles/205087-inbios-international-gains-eua-for-covid-19-antibody-test

InBios International Gains EUA for COVID-19 Antibody Test

October 29, 2021

Seattle, Wash.-based Inbios International has received an Emergency Use Authorization (EUA) from the FDA for its SCoV-2 Detect Neutralizing Ab ELISA test.

The test, which detects neutralizing antibodies to the SARS-CoV-2 virus from human serum and plasma, is designed to identify individuals who have had an adaptive immune response to SARS-CoV-2, indicating a recent or prior infection.

The new authorization is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988, the FDA said.

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