(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.
QuidelOrtho Corporation QDEL recently announced that it has been granted a CLIA Waiver by the FDA, which applies to its new Sofia 2 SARS Antigen+ FIA (fluorescent immunoassay). The Sofia 2 SARS ...
LOS ANGELES, Jan. 7, 2025 /PRNewswire/ -- CovarsaDx ®, a prominent Clinical Research Organization (CRO) renowned for its in vitro diagnostics (IVDs) and medical device expertise, announced today that ...
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