bioMérieux, a world leader in the field of in vitro diagnostics, has announced the launch of the Parvovirus B19 R-gene® kit, a new CE-marked ARGENE® real-time PCR test, used for the detection and quantification of the three Parvovirus B19 genotypes.
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bioMérieux receives De Novo FDA Authorization for its BIOFIRE® Joint Infection (JI) Panel
04 Mai, 2022Joint infections (“septic arthritis”) are serious infections involving either native or prosthetic joints. They are medical emergencies which can occur at all ages, and can lead to functional joint impairment, long-lasting disability, and may even be life-threatening. The number of prosthetic...
bioMérieux launches a new assay for vitamin D testing: VIDAS® 25 OH Vitamin D Total
30 September, 2013
bioMérieux, a world leader in the field of in vitro diagnostics, has announced the launch of VIDAS® 25 OH Vitamin D Total for the measurement of total vitamin D levels in human serum and plasma.
bioMérieux makes a significant acquisition in molecular biology in the U.S.
03 September, 2013
bioMérieux, a world leader in the field of in vitro diagnostics, announces that it has entered into an agreement to acquire BioFire Diagnostics Inc., a privately held U.S.-based company specialized in molecular biology. BioFire invented, manufactures and commercializes its multiplex PCR FilmArray® system, a simple and rapid molecular biology solution dedicated to the diagnosis of infectious diseases. Thanks to its syndromic approach to the diagnosis of these diseases, FilmArray® contributes to improving patient care and reducing healthcare spending. By further stimulating sales of this system and expanding its menu, bioMérieux intends to strengthen the Company’s position as a major player in infectious disease diagnostics, its core strategic focus.
bioMérieux Announces U.S. FDA Clearance for VITEK® MS, a Revolutionary Technology which Reduces Microbial Identification from Days to Minutes Reinforcing Medical Value of Diagnostics
22 August, 2013
bioMérieux today announced that it has been granted U.S. FDA 510(k) de novo clearance for VITEK® MS, the first clinical mass spectrometry MALDI-TOF-based system available in the U.S. for rapid identification of disease-causing bacteria and yeast. VITEK® MS is the latest addition to the VITEK® family of products, and it is the first system to enable detection of disease causing microorganisms in minutes: this game-changing technology can significantly improve patient care. The Cleveland Clinic recently named the technique as one of the Top Ten Breakthrough Medical Technologies of 2013.
bioMérieux Announces U.S. FDA Clearance for VITEK® MS
21 August, 2013
International Experts Join Forces against Superbugs at the 4th World Forum on Healthcare-Associated Infections and Antimicrobial Resistance
27 Juni, 2013
bioMérieux commits to supporting expert-defined global priorities.
bioMérieux receives CE marking for VIDAS® 3,the new generation of VIDAS®
20 Juni, 2013
bioMérieux, a world leader in the field of in vitro diagnostics, announces that VIDAS® 3, the new generation of VIDAS®, has been granted CE marking. This instrument, which further enriches the offering of the VIDAS immunoassay product range, VIDAS and mini VIDAS®, is now commercially available in Europe and the countries that recognize the CE marking.
bioMérieux Receives FDA Approval for THxIDTM-BRAF Companion Diagnostic Test
30 Mai, 2013
bioMérieux, a world leader in the field of in vitro diagnostics, today announced that its novel molecular test THxIDTM-BRAF received PMA* approval from the FDA (Food and Drug Administration) for commercialization in the United States. This unique test is intended for the qualitative and simultaneous detection of both BRAF V600E and V600K mutations in late stage metastatic melanoma tumor samples.