bioMérieux announces U.S. FDA-CBER (1) Premarket Notification 510(k) clearance of the recently launched, innovative polycarbonate BacT/ALERT BPA and BacT/ALERT BPN culture bottles for microbial quality control testing of leukocyte-reduced single units of whole blood platelet concentrates (WBPC).
News24 March, 2020
bioMérieux, a world leader in the field of in vitro diagnostics, today announced that its subsidiary, BioFire Defense, has received Emergency Use Authorization by the U.S. Food and Drug Administration of its BIOFIRE® COVID-19 test for use in CLIA moderate and high complexity clinical...
bioMérieux, a major player in the field of microbiological controls for the pharmaceutical and agri-food industries, introduces VITEK®2 Compact, the newest addition to its range of automated identification systems.
bioMérieux has received CE Mark certifications for all of its in vitro diagnostic (IVD) products currently marketed in the European Union (EU). In compliance with the requirements of the 98/79/EC directive for CE Marking, which became applicable on December 7th, 2003, these certifications enable bioMérieux to continue to sell its products within the European Union after this date.