Culture-Based Short-Term Incubation Antimicrobial Resistance Assay

QIV · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.1655

Classification

FDA Product Code: QIV
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.1655
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A system for detection of microorganisms and antimicrobial resistance using reporter expression is an in vitro diagnostic device intended for the detection and identification of live microorganisms and the detection of associated antimicrobial drug susceptibility or resistance in specimens from patients at risk of colonization or suspected of infection.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 2

Source

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