QXT

Infliximab Test System

Product code

QXT

Device name

Infliximab Test System

Device class

Class 2

21 CFR

21 CFR 862.3115

Medical specialty

Clinical Toxicology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

0 (direct download)

510(k) clearances (all years, FDA)

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

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.

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

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-09-29.