Product code OUF

Device name
Everolimus Immunoassay
Medical specialty
Clinical Toxicology
Device class
2
Regulation number
862.3840
Review panel
TX
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
To quantify everolimus in whole blood.
Source
FDA openFDA device classification dataset