DeviceClearance

Product code QIV— Microbiology

cobas vivoDx MRSA

Classification name
Culture-Based Short-Term Incubation Antimicrobial Resistance Assay
Device class
Class 2
Regulation
21 CFR 866.1655
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QIV under 21 CFR 866.1655, via openFDA

Market context for product code QIV

FDA has cleared 1 device under product code QIV, all in 2019, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QIV

Recent clearances under product code QIV

Data sourced from openFDA. This site is unofficial and independent of the FDA.