DeviceClearance

Product code QDR— Clinical Toxicology

QMS Plazomicin Immunoassay

Classification name
Plazomicin Test System, Immunoassay
Device class
Class 2
Regulation
21 CFR 862.3460
Advisory panel
Clinical Toxicology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QDR under 21 CFR 862.3460, via openFDA

Market context for product code QDR

FDA has cleared 1 device under product code QDR, all in 2018, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QDR

Recent clearances under product code QDR

Data sourced from openFDA. This site is unofficial and independent of the FDA.