510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QXTClass II

Infliximab Test System

21 CFR 862.3115 / Clinical Toxicology
FDA source (opens on fda.gov)

QXT is the FDA product code for Infliximab Test System, a class II device type, regulated under 21 CFR 862.3115. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QXT
Device name
Infliximab Test System
FDA 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.
Regulation
21 CFR 862.3115
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QXT

By decision year
1 clearance under product code QXT with a decision year between 2023 and 2023, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QXT by decision year
YearClearances
20231

Applicants with the most clearances

Product code QXT
Applicants holding the most 510(k) clearances under product code QXT
ApplicantClearances
Procisedx, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code