510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OAVClass II

Mycophenolic Acid Test System

21 CFR 862.3840 / Clinical Toxicology
FDA source (opens on fda.gov)

OAV is the FDA product code for Mycophenolic Acid Test System, a class II device type, regulated under 21 CFR 862.3840. FDA's definition for this code reads: "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". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OAV
Device name
Mycophenolic Acid Test System
FDA 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.
Regulation
21 CFR 862.3840
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code OAV

By decision year
3 clearances under product code OAV with a decision year between 2007 and 2011, 2007 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OAV by decision year
YearClearances
20071
20081
20111

Applicants with the most clearances

Product code OAV
Applicants holding the most 510(k) clearances under product code OAV
ApplicantClearances
Roche Diagnostics GmbH1
Siemens Heatlhcare Diagnostics, Inc.1
Thermo Fisher Scientific Oy1

Companies listing this code with FDA

Companies whose registered establishments list this code