Product code PUJ

Device name

Voriconazole Test System

Medical specialty

Clinical Toxicology

Device class

2

Regulation number

862.3970

Review panel

TX

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset