bioMérieux announces the introduction of NucliSens miniMAG and NucliSens Magnetic Extraction Reagents, two key components of the company’s next generation nucleic acid extraction technology.
U.S. FDA Premarket Notification 510(k) Clearance of Polycarbonate BacT/ALERT® Culture Bottles for Microbial QC Testing of Leukocyte-Reduced Single Units of Whole Blood Platelet Concentrates (WBPC)
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).
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.