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Monday, April 20, 2020 8:39:32 AM
4/20/20, 7:36 AM
07:36 AM EDT, 04/20/2020 (MT Newswires) -- NovaBay Pharmaceuticals (NBY) said pre-market Monday that it has signed a deal with Shenzhen Microprofit Biotech Co., Ltd. to become the exclusive US distributor of the fluorecare SARS-CoV-2 IgG & IgM antibody point of care test kit to be administered by health care professionals.
The finger prick test determines the presence of COVID-19 or a potential indication of antibody immunity to the respiratory disease for which currently there is no treatment, according to NovaBay.
The pharmaceutical firm said that it will submit the fluorecare test kit to the US Food and Drug Administration under Emergency Authorization Use. It will also seek a permanent FDA 510(k) clearance for the test kit for continued use once the federal government declares an end to the state of emergency.
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