VITEK COMPACT PRO receives FDA 510(k) Clearance
bioMérieux has received FDA 510(k) clearance for VITEK COMPACT PRO, aimed at improving diagnostics in clinical and industrial laboratories.
bioMérieux has received FDA 510(k) clearance for VITEK COMPACT PRO, aimed at improving diagnostics in clinical and industrial laboratories.
The NephroCheck test relies on the detection of two urinary biomarkers: TIMP-2 and IGFBP-7. Both are produced by stressed kidney cells before the onset of AKI.
The Class I recall includes all lots of gram-positive AST cards with cefoxitin and oxacillin tests; use of the devices may cause serious injury or death.
The federal plan to combat and prevent highly resistant bacteria anticipates a stronger role for diagnostic testing and laboratory surveillance.
Read MorebioMerieux sepsis facility expansion will help address the global public health threat of sepsis and meet the related demand for microbial detection.
Read MoreIn vitro diagnostics manufacturer bioMérieux has appointed Stefan Willemsen, MA, as president and CEO of bioMérieux Inc. He will lead the company’s operations in its recently created North and Latin America region.
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