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Re: OPD2018 post# 425

Friday, 03/27/2020 3:59:49 PM

Friday, March 27, 2020 3:59:49 PM

Post# of 27112
The FDA announced the rule to allow company to market IgG based test kit on March 16, which also requires company to submit EUA within 15 days. ABMS is the only US based IgG test kit provider, who starts marketing under FDA guidance on March 19. Their accuracy data is shown in another post here. They have been in business for many years and have 128 medical devices shown on FDA website