Product code QDR

Device name

Plazomicin Test System, Immunoassay

Medical specialty

Clinical Toxicology

Device class

2

Regulation number

862.3460

Review panel

TX

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Ineligible

Definition

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.

Source

FDA openFDA device classification dataset