NovaBay inks COVID-19 antibody test distribution deal

LabPulse.com staff writers
Apr 19, 2020
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NovaBay Pharmaceuticals has signed an agreement with Shenzhen Microprofit Biotech to distribute its COVID-19 rapid point-of-care test for immunoglobulin G (IgG) and immunoglobulin M (IgM) in the U.S.

Fluorecare SARS-CoV-2 IgG & IgM Antibody Combined detects COVID-19 antibodies in a patient's blood and produces results in about 10 minutes, according to the firm. It has International Organization for Standardization (ISO) 13485 and CE Mark certification. NovaBay plans to submit the test kit to the U.S. Food and Drug Administration (FDA) under its emergency use authorization (EUA) program, as well as the agency's permanent 510(k) pathway.

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