By Sabela Ojea

 

LumiraDx said Friday that it submitted a dual U.S. Food and Drug Administration medical devices application for the clearance of its Covid-19 ultra test.

The diagnostic technology company said its 510(k) dual submission aims to receive approval for the commercial distribution at point of care of the LumiraDx platform, which enables lab-comparable performance across a broad menu of diagnostic assays, in conjunction with its Covid-19 test and Covid-19 Ag Quality control swab kit.

The company had received several emergency use authorizations for its Covid-19 tests during the pandemic.

At 14:50 E.T., shares rose 2.7%, to 44 cents.

 

Write to Sabela Ojea at sabela.ojea@wsj.com

 

(END) Dow Jones Newswires

June 30, 2023 15:11 ET (19:11 GMT)

Copyright (c) 2023 Dow Jones & Company, Inc.
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