Product code DEX

Device name

Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control

Medical specialty

Immunology

Device class

1

Regulation number

866.5420

Review panel

IM

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Source

FDA openFDA device classification dataset