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.

Recommended For You


To ensure this doesn’t happen in the future, please enable Javascript and cookies in your browser.
Is this happening to you frequently? Please report it on our feedback forum.
If you have an ad-blocker enabled you may be blocked from proceeding. Please disable your ad-blocker and refresh.