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Company to submit the ISO 13485 and CE Mark certified fluorecare &test kit under FDAs EAU and 510(k) clearance for U.S. commercial use. EMERYVILLE, Calif.--(BUSINESS WIRE)--Apr. 20, 2020- to become the exclusive U.S. distributor of a rapid, finger prick test to rapid igm rapid igm rapid test kit with ce mark iso 13485NovaBay Pharmaceuticals Signs Agreement to Distribute rapid igm rapid igm rapid test kit with ce mark iso 13485The fluorecare test kit has been validated through widely used RT-PCR testing to detect immunoglobulin M (IgM), which is the first antibody produced in response to NovaBay to distribute antibody-based rapid COVID-19 rapid igm rapid igm rapid test kit with ce mark iso 13485Apr 21, 2020The test kit has been granted ISO 13485 and CE Mark approval. IgM is the first antibody produced in response to initial exposure to the COVID-19 antigen, and IgG provides a potential indication of antibody-based immunity to COVID-19. The company intends to submit the fluorecare test kit to the US Food and Drug Administration (FDA) under rapid igm rapid igm rapid test kit with ce mark iso 13485

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