OAV

Mycophenolic Acid Test System

Product code: OAV
Device name: Mycophenolic Acid Test System
Device class: Class 2
21 CFR: 21 CFR 862.3840
Medical specialty: Clinical Toxicology
Marketing pathway: 510(K)
Flag: Third-party review eligible
510(k) clearances (all years, FDA): 3 (all years; only the last 3 years are listed here)

FDA classification 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.

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

Official FDA classification page: OAV

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