Product code QIV

Device name: Culture-Based Short-Term Incubation Antimicrobial Resistance Assay
Medical specialty: Microbiology
Device class: 2
Regulation number: 866.1655
Review panel: MI
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Ineligible
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.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
DEN190016	cobas vivoDx MRSA	Roche Molecular Systems, Inc.	2019-12-05

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00875197005813	cobas&#x00AE vivoDx MRSA Collection and Transport Kit	Roche Molecular Systems, Inc.	2020-01-15
00875197005820	cobas&#x00AE vivoDx MRSA Control Media	Roche Molecular Systems, Inc.	2020-01-15
00875197006193	cobas&#x00AE vivoDx MRSA	Roche Molecular Systems, Inc.	2020-01-15
07613336129487	cobas&#x00AE vivoDx System	Roche Molecular Systems, Inc.	2020-01-15

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