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System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species

FDA product code NIJ · 6 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.1640
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2002-05-01 – 2024-11-21

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

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