Product code DFM

Device name

Ige, Ferritin, Antigen, Antiserum, Control

Medical specialty

Immunology

Device class

2

Regulation number

866.5510

Review panel

IM

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Source

FDA openFDA device classification dataset