The US Food and Drug Administration in January modified existing 510(k) clearances for several firms, including Becton Dickinson and Roche, while it granted new clearances for diagnostic instruments and assays from Medica, Selux Diagnostics, and others, according to the agency website.

LumiraDx said Monday that it had nabbed US Food and Drug Administration Emergency Use Authorization and UK Health Security Agency Coronavirus Test Approvals process validation for LumiraDx's laboratory-based multiplex test for COVID-19 and influenza A and B.

Visby Medical's respiratory panel test has received Emergency Use Authorization from the US Food and Drug Administration, according to a letter from the agency.

LumiraDx said on Wednesday that it has received CE marking for a molecular SARS-CoV-2 test and an assay that tests for both SARS-CoV-2 and influenza virus.