QIV · Class II · 21 CFR 866.1655

FDA Product Code QIV: Culture-based Short-term Incubation Antimicrobial Resistance Assay

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.

Leading manufacturers include Roche Molecular Systems, Inc..

1
Total
0
Cleared
261d
Avg days
2019
Since

FDA 510(k) Cleared Culture-based Short-term Incubation Antimicrobial Resistance Assay Devices (Product Code QIV)

1 devices
1–1 of 1
Not Cleared Dec 05, 2019
cobas vivoDx MRSA
DEN190016
Roche Molecular Systems, Inc.
Microbiology · 261d

About Product Code QIV - Regulatory Context