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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State Liquid
Technical Method Enzyme-mimicking assay with MPA concentration inversely proportional to the formation of NADH.
Target Area Renal and Cardiac Transplant Patients
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeOAV
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.3840
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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