QIV

Culture-Based Short-Term Incubation Antimicrobial Resistance Assay

Product code

QIV

Device name

Culture-Based Short-Term Incubation Antimicrobial Resistance Assay

Device class

Class 2

21 CFR

21 CFR 866.1655

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

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

FDA classification 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.

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