DeviceClearance

Product code OAV— Clinical Toxicology

CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS

Classification name
Mycophenolic Acid Test System
Device class
Class 2
Regulation
21 CFR 862.3840
Advisory panel
Clinical Toxicology
Total cleared
3
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code OAV under 21 CFR 862.3840, via openFDA

Market context for product code OAV

FDA has cleared 3 devices under product code OAV between 2007 and 2011, filed by 3 applicant companies. 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.

Clearances per year

Top applicants under product code OAV

Recent clearances under product code OAV

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