Chembio Diagnostics Inc.

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Chembio Diagnostics Says Intend To Work With FDA To Seek To Establish Priority For Igm/Igg EUA

Published: 12/04/2020 13:18 GMT
Chembio Diagnostics Inc. (CEMI) - Chembio Diagnostics - on Dec 3, Received From FDA Response to Request for Eua for Dpp Sars Cov-2 Igm/igg With Dpp Micro Reader for Use in Detection of Antibodies to Sars-cov-2.
Chembio Diagnostics - Response Letter States, Given Volume of Eua Requests It Has Received, FDA is Prioritizing Review of Eua Requests for Tests.
Chembio Diagnostics - Response Letter Further States That the FDA Has Determined That Review of Igm/igg Eua Request is Not a Priority.
Chembio Diagnostics - Intend to Work With FDA to Seek to Establish Priority for Igm/igg Eua.
Chembio Diagnostics - Response Letter Received for Igm/igg Eua Has No Effect on Pending Request Submitted for Eua for Dpp Sars-cov-2 Antigen Test System.