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Mr. Disbrow concluded, "We have received further confirmation that the COVID-19 IgG/IgM Rapid Test manufactured by Zhejiang Orient Gene is in the approval process with NMPA.
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Mar 26, 2020SD iosensor has notified FDA that it has validated the Standard Q OVID-19 IgM/IgG Rapid Test and that the test is being offered as set forth in FDAs March 16, 2020 guidance. FDA has posted these notifications on its website. Q2 Has it been validated? A2 Yes.
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