Chembio submits De Novo request SARS-CoV-2 Antigen test system

Dec. 06, 2021 9:29 AM ETChembio Diagnostics, Inc. (CEMI)By: Jonathan Block, SA News Editor

Close up of the face of a senior female patient being tested for Covid-19

Basilico Studio Stock/iStock via Getty Images

  • Chembio Diagnostics (CEMI -7.9%) has submitted a De Novo/510(k) Request to the FDA for its DPP SARS-CoV-2 Antigen test system.
  • The system is designed to detect SARS-CoV-2 antigens in 20 minutes with a nasal swab and read with a DPP Micro Reader or DPP Micro Reader 2 optical analyzer.
  • The systems was developed with funding from the Biomedical Advanced Research and Development Authority ("BARDA").
  • The test was recently approved by authorities in South Africa.

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