bioMérieux announces that following prospective management studies on its VIDAS D-Dimer test resulting in FDA approval and CE marking, the VIDAS D-Dimer New test has been renamed VIDAS D-Dimer Exclusion™. This name change will more accurately reflect the new intended use of the VIDAS D-Dimer Exclusion test, and also reinforce awareness of the significant role D-dimers can play in exclusion strategies for thromboembolic disease.
A major player in the field of infectious disease, bioMérieux, and its exclusive distributor for South Africa, Omnimed, have just won a most important tender for the National Health Laboratory Services of South Africa as regards the fight against the AIDS virus.
A world leader in the field of in vitro diagnostics, with over 40 years experience in infectious diseases, bioMérieux SA recently confirmed its commitment to the field of emergency diagnostics through its presence at the 25th International Symposium on Intensive Care and Emergency Medicine in Brussels on March 21–25, 2005.
NucliSens® miniMAG™, the first product from bioMérieux’s next generation nucleic acid extraction platform now available.
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.