Division of Institut Merieux/bioMerieux SA
Latest From BioMerieux Inc.
A group of antimicrobial susceptibility test manufacturers are working with US FDA regulators to hasten the clearance process for their products. The agency recent convened a workshop at its Maryland headquarters to help address the issue.
FDA's increasingly popular de novo classification pathway for moderate-risk devices that have no predicate accounted for five marketing go-aheads last month, four of which were for in vitro diagnostics.
In this earnings review, we pick out the high achievers and underperformers from the companies that released quarterly results in the past week. Reports from J&J, ResMed, bioMérieux, St. Jude Medical and more.
The agency cleared BioFire's diagnostic system FilmArray to detect multiple pathogens that can cause central nervous system infections. The test is meant to be used in conjunction with other clinical and laboratory tests.
- In Vitro Diagnostics
- Therapeutic Areas
- BioMerieux Vitek Inc.
- North America
- Parent & Subsidiaries
- Institut Merieux
- Merieux Alliance
- Senior Management
- Philippe Sans, Pres.
- Contact Info
Phone: (314) 731-8500
595 Anglum Rd.
Hazlewood, MO 63042
All set! This article has been sent to firstname.lastname@example.org.
All fields are required. For multiple recipients, separate email addresses with a semicolon.