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jq1234

05/21/20 6:44 PM

#232630 RE: DewDiligence #232618

FDA Posts List Of Antibody Tests Removed From "Notification List"

Antibody tests on this new removal list include those voluntarily withdrawn from the notification list by the test’s commercial manufacturer and those for which there is not a pending Emergency Use Authorization (EUA) request or issued EUA.


https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-promised-transparency-antibody-tests

Currently authorized serology tests included only 13 and 2 of them from ABT. Here are the performances of remaining serology test under currently EUA:


https://www.fda.gov/medical-devices/emergency-situations-medical-devices/eua-authorized-serology-test-performance