Home » InBios International Gains EUA for COVID-19 Antibody Test
InBios International Gains EUA for COVID-19 Antibody Test
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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