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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mycophenolic acid test system
Regulation Description Sirolimus test system.
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.
Product CodeOAV
Regulation Number 862.3840
Device Class 2

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