FDA Product Code QDR: Plazomicin Test System, Immunoassay
A Plazomicin Test System Is A Device Intended To Measure Plazomicin In Human Specimens. Measurements Obtained By This Device Are Used In Monitoring Levels Of Plazomicin To Ensure Appropriate Therapy In Patients With Complicated Urinary Tract Infection.
Leading manufacturers include Microgenics Corporation.
List of Plazomicin Test System, Immunoassay devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Plazomicin Test System, Immunoassay devices (product code QDR). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Toxicology FDA review panel. Browse all Toxicology devices →