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Mycophenolic Acid Test System

FDA product code OAV · 3 cleared devices

Class 2 Clinical Toxicology
Regulation
21 CFR 862.3840
Review panel
TX
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2007-02-16 – 2011-10-07

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.

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