DeviceClearance

Product code QXT— Clinical Toxicology

Procise IFX

Classification name
Infliximab Test System
Device class
Class 2
Regulation
21 CFR 862.3115
Advisory panel
Clinical Toxicology
Total cleared
1
First cleared
Most recent

FDA classification definition

“An infliximab test system intended for the measurement of an infliximab as an aid in the management of patients with Crohn’s disease or ulcerative colitis.”

— U.S. Food and Drug Administration, device classification record for product code QXT under 21 CFR 862.3115, via openFDA

Market context for product code QXT

FDA has cleared 1 device under product code QXT, all in 2023, 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 QXT

Recent clearances under product code QXT

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