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Business Development

Laboratory and Research

Yale Regulatory Support

Yale Office of Public Health Practice

Advisory board

Past team members

  • Sumaira Akbarzada
  • Kashif Ahmed
  • Taiwo Ajibola
  • Kimberly Bako
  • Eli Bierman
  • Megan Briggs
  • Victor Elisha
  • Lily Kitfield-Vernon
  • Hunter Larson
  • Sarah Megiel
  • Yashna Nainani
  • Samson Osuntokun Oluwale
  • Leah Salzano
  • Catherine Santiago
  • Wells Tu
  • Alison Zerbib

Important Regulatory Information about SalivaDirect™

SalivaDirect™has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.