Voriconazole Test System

PUJ · Class II — Moderate Risk (510(k) clearance required) · Clinical Toxicology · 21 CFR 862.3970

Classification

FDA Product Code: PUJ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.3970
Review panel: TX
Medical specialty: Clinical Toxicology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A voriconazole test system is a device intended to measure voriconazole in human serum. Measurements obtained by this device are used in monitoring levels of voriconazole to ensure appropriate therapy.

Market data

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

Source

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