LumiraDx Submits Medical Device Application To FDA For COVID Ultra Test

(RTTNews) - LumiraDx Limited (LMDX), Friday announced the submission of its first 510(k) application to the U.S. Food and Drug Administration (FDA) for the clearance of its 5-minute COVID Ultra Test.

LumiraDx submitted a traditional 510(k) Dual Submission for LumiraDx SARS-CoV-2 Ag Ultra with CLIA Waiver for the commercial distribution at point of care of the LumiraDx Platform, including the LumiraDx Instrument, with the LumiraDx SARS-CoV-2 Antigen (Ag) Ultra test, and the LumiraDx SARS-CoV-2 Ag Quality Control Swab Kit.

LumiraDx had earlier received various Emergency Use Authorizations (EUA) for its SARS-CoV-2 Ag tests during the pandemic.