NovaBay inks COVID-19 antibody test distribution deal

2020 04 16 18 56 8041 Virus Coronavirus Sars Co V 2 400

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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