Product code QYD

Device name

Adalimumab Assay

Medical specialty

Clinical Toxicology

Device class

2

Regulation number

862.3115

Review panel

TX

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

An in vitro diagnostic device intended for the measurement of adalimumab, an anti-tumor necrosis factor alpha monoclonal antibody

Source

FDA openFDA device classification dataset