PUJ

Voriconazole Test System

Product code: PUJ
Device name: Voriconazole Test System
Device class: Class 2
21 CFR: 21 CFR 862.3970
Medical specialty: Clinical Toxicology
Marketing pathway: 510(K)
510(k) clearances (all years, FDA): 1 (all years; only the last 3 years are listed here)

FDA classification 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.

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

Official FDA classification page: PUJ

Classification and pathway per current FDA publications. Data from openFDA (CC0).