FDA product code OAV

Mycophenolic Acid Test System

Clinical Toxicology·Class 2·21 CFR 862.3840
US regulatory classifications
US Product Code (FDA)
OAV
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 862.3840
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Medical specialty
Clinical Toxicology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
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.

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About this record

Mycophenolic Acid Test System is a medical device type in the Clinical Toxicology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.