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With GENE-UP® PROBIOTIC SPECIES ID, bioMérieux introduces a first-of-its-kind commercialized species-level identification PCR solution for in-house quality control teams and external laboratory partners.
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bioMérieux submits 510(k) to U.S. FDA for the latest versions of the BIOFIRE® FILMARRAY® Gastrointestinal Panels to enhance detection of gastrointestinal pathogens
bioMérieux, a world leader in the field of in vitro diagnostics, today announces the submission of the BIOFIRE® FILMARRAY® Gastrointestinal 1.1 (GI1.1) Panel and the BIOFIRE® FILMARRAY® Gastrointestinal 1.1 (GI1.1) Panel Mid to the U.S. Food and Drug Administration (FDA) for 510(k) review. These PCR* molecular panels test 22 and 11, respectively, of the most common bacteria, viruses, and parasites associated with gastroenteritis, all from one sample, with results available in approximately one hour. -
Advancing Women’s Health with Rapid Diagnostics: bioMérieux files a Dual 510(k) /CLIA Waiver application to the FDA for the BIOFIRE® SPOTFIRE® Vaginitis Panel
bioMérieux, a world leader in the field of in vitro diagnostics, has submitted a Dual 510(k)/CLIA Waiver application to the U.S. Food and Drug Administration (FDA) for the BIOFIRE® SPOTFIRE® Vaginitis (VG) Panel. This automated, multiplex PCR test can simultaneously detect the most common causes of vaginitis in 20 minutes, directly at the point of care. With this submission, bioMérieux is intending to expand into women’s and sexual health, bringing rapid and accurate diagnostics closer to patients. -
bioMérieux introduces Salmonella testing kit on GENE-UP® TYPER to support root cause analysis in the food industry
bioMérieux, a world leader in the field of in vitro diagnostics, today introduces the launch of GENE-UP® TYPER SLM, a new real-time PCR solution supporting rapid root cause analysis by discriminating Salmonella in the food industry environments.
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