Product code DDK

Device name

Beta-2-Glycoprotein Iii, Antigen, Antiserum, Control

Medical specialty

Immunology

Device class

1

Regulation number

866.5440

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