Erik T. Engelson
Debkishore Mitra, Ph.D.
Tony Allen has served as our Chief Operations Officer since September 2021. From May 2018 to September 2021, Mr. Allen served as Vice President and Head of Global Internal Manufacturing at Ortho-Clinical Diagnostics, Inc., an in vitro diagnostics company. Mr. Allen served as Vice President and General Manager at Gap Partners, Inc., a metal fabrication company, from March 2017 to May 2018, Global Senior Project Management Office Head at Alcon Inc., an eye care device company, from March 2016 to March 2017 and Vice President of Operations at Accriva Diagnostics Holdings, Inc., a medical equipment and supplies manufacturing company, from October 2015 to March 2016. Prior to that he served in various operations and leadership roles at DJO Global, Inc., an orthopedic medical device company, for approximately eight years and at NEC Computers International, an information technology and electronics company, for approximately nine years. Mr. Allen received a T5 in telecommunications and radio communications from the Department of Marine Radio and Radar, Limerick, Ireland and an Executive M.B.A. from Aberdeen University.
This home test kit has not been FDA cleared or approved. This home test kit has been authorized by FDA under EUA. This home test kit has been authorized only for the testing of nasal swabs for detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This home test kit is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of IVDs 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 declaration is terminated or revoked sooner.