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Tuesday, July 13, 2021 11:21:01 AM
Austin, Texas, July 13, 2021 (GLOBE NEWSWIRE) -- Umbra Applied Technologies Group, Inc (OTC Pink: UATG) Affiliate and strategic partner, Bacter Scientific, Inc., a privately held, molecular diagnostics and infection detection medical research company, announced today that the Office of In Vitro Diagnostics and Radiological Health and Office of Product Evaluation and Quality within the U.S. Food and Drug Administration (FDA) accepted the company’s request for a Pre-Emergency Use Authorization (PEUA). The FDA’s Division of Program Operations and Management team has conducted and concluded its preliminary review of the Novi hand-held point-of-care test for the qualitative detection of novel coronavirus (COVID-19). The proprietary hand-held virus detection unit is now in queue for “substantive review” to be approved for emergency use.
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