Mycophenolic Acid Test System

OAV · Class II — Moderate Risk (510(k) clearance required) · Clinical Toxicology · 21 CFR 862.3840

Classification

FDA Product Code: OAV
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.3840
Review panel: TX
Medical specialty: Clinical Toxicology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 3
Registered establishments: 6

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown