Infliximab Test System

QXT · Class II — Moderate Risk (510(k) clearance required) · Clinical Toxicology · 21 CFR 862.3115

Classification

FDA Product Code: QXT
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.3115
Review panel: TX
Medical specialty: Clinical Toxicology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

An infliximab test system intended for the measurement of an infliximab as an aid in the management of patients with Crohns disease or ulcerative colitis.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown