BioFire
CDC to Withdraw EUA for COVID-19 Test; FDA Revokes Three Other EUAs for Non-Use, Agency Clearance
The EUAs for Gravity and Curative's tests were revoked because they are no longer used by the companies, while BioFire's test now has FDA clearance.
BioFire Dx Receives First FDA Marketing Clearance for SARS-CoV-2 Respiratory Panel
The test is the first COVID-19 assay to transition from Emergency Use Authorization to a cleared regulatory status.
Some tests that detect multiple SARS-CoV-2 genes are serendipitously signaling new viral variants while still effectively detecting infections.
Roche Diagnostics, Beckman Coulter, BioMérieux, Mesa Biotech Receive FDA 510(k) Clearances in November
The BioFire Defense subsidiary of BioMérieux obtained clearance for its FilmArray Global Fever Panel External Control Kit, used with the FilmArray Global Fever Panel.
BioMérieux Coronavirus Test Gets FDA OK for Use With Pooled Samples
The test, developed by BioMérieux subsidiary BioFire Defense, first received Emergency Use Authorization from the US Food and Drug Administration in March.
Oct 22, 2020
BioMérieux Q3 Revenues Increase 21 Percent
Feb 26, 2020
BioMérieux Reports 11 Percent Revenue Growth in Q4
Jan 14, 2020
BioMérieux Submits 43-Target BCID2 Test to FDA
Apr 30, 2019
Apr 24, 2019
BioMérieux Q1 Revenues Up 8 Percent
Feb 27, 2019