News
bioMérieux, a world leader in the field of in vitro diagnostics, today announces that its BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini has received U.S. Food and Drug Administration (FDA) Special 510(k) clearance and CLIA-waiver (Clinical Laboratory Improvement Amendments).
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bioMérieux receives US FDA 510(k) clearance for its AST System VITEK® REVEAL™
bioMérieux, a world leader in in vitro diagnostics, today announces that its VITEK® REVEAL™ AST System, reporting results directly from positive blood cultures, has received U.S. Food and Drug Administration (FDA) 510(k) clearance. -
Recombinant Factor C Methods for Endotoxin Testing: Towards Sustainable Development and Reliable Supply Chain
In 2020, vaccine research received significant attention as researchers were engaged in the race to develop an effective vaccine against SARS-CoV-2 worldwide. More broadly, the entire pharmaceutical industry is experiencing this rapid growth. In this context, supply chain sustainability is crucial. The use of horseshoe crab blood in the quality and safety control process is essential to ensure the safety of injectable and implantable pharmaceutical products. Environmental challenges are key in the debate around the use of traditional Limulus Amebocyte Lysate (LAL) methods in favor of more sustainable methods such as recombinant Factor C (rFC). -
USDA Awards bioMérieux GENE-UP® Pathogenic E. coli (PEC) as Method of Choice for Shiga Toxin-Producing E. coli (STEC) Detection in USDA Food Safety and Inspection Service (USDA-FSIS) Laboratories
GENE-UP® PEC assay is a real-time PCR-based AOAC validated solution for the meat, produce, and food safety industry.
Enabling Decision-Making
- ANTIMICROBIAL STEWARDSHIP
- SEPSIS
- FOOD SAFETY & QUALITY
- PHARMA QUALITY CONTROL
- COVID-19
- ANTIMICROBIAL STEWARDSHIP
- SEPSIS
- FOOD SAFETY & QUALITY
- PHARMA QUALITY CONTROL
- COVID-19