System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
Medical specialty
Microbiology
Device class
2
Regulation number
866.1640
Review panel
MI
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
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