Product code OAV

Device name

Mycophenolic Acid Test System

Medical specialty

Clinical Toxicology

Device class

2

Regulation number

862.3840

Review panel

TX

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Definition

An in vitro diagnostic reagent system intended for use in the quantitative determination of total mycophenolic acid in human serum or plasma as an aid in the management of mycophenolic acid therapy in renal and cardiac transplant patients.

Source

FDA openFDA device classification dataset