NIJ

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

Product code

NIJ

Device name

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

Device class

Class 2

21 CFR

21 CFR 866.1640

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

0 (direct download)

510(k) clearances (all years, FDA)

6 (all years; only the last 3 years are listed here)

FDA classification 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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-11-21.