DeviceClearance

Product code PUJ— Clinical Toxicology

ARK Voriconazole II Assay Test System

Classification name
Voriconazole Test System
Device class
Class 2
Regulation
21 CFR 862.3970
Advisory panel
Clinical Toxicology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code PUJ under 21 CFR 862.3970, via openFDA

Market context for product code PUJ

FDA has cleared 1 device under product code PUJ, all in 2017, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PUJ

Recent clearances under product code PUJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.