FDA Product Code NIJ: System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
The In Vitro Device Is Intended To Detect The Presence Of The Vana And Vanb Genes In Isolated Colonies Of Enterococcus Spp. As A Marker For Vancomycin Resistance Using Dna Probe Technology
Leading manufacturers include Cepheid.
List of System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species devices (product code NIJ). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →