FDA Product Code OAV: Mycophenolic Acid Test System
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.
Leading manufacturers include Roche Diagnostics and Thermo Fisher Scientific.
3
Total
3
Cleared
237d
Avg days
2007
Since
FDA 510(k) Cleared Mycophenolic Acid Test System Devices (Product Code OAV)
3 devices
Cleared
Dec 19, 2008
CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS
Thermo Fisher Scientific
Toxicology
247d
Cleared
Feb 16, 2007
ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS
Roche Diagnostics
Toxicology
87d