QDR

Plazomicin Test System, Immunoassay

Product code

QDR

Device name

Plazomicin Test System, Immunoassay

Device class

Class 2

21 CFR

21 CFR 862.3460

Medical specialty

Clinical Toxicology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).