FDA product code QXT

Infliximab Test System

Clinical Toxicology·Class 2·21 CFR 862.3115
US regulatory classifications
US Product Code (FDA)
QXT
View Product Code Classification →
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 862.3115
View CFR Regulation →
Medical specialty
Clinical Toxicology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

Search keywords
About this record

Infliximab Test System is a medical device type in the Clinical Toxicology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.