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

NIJ · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.1640

Classification

FDA Product Code: NIJ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.1640
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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

Market data

Cleared 510(k) submissions: 6
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown