Product code NWG

Device name

Autoantibodies, Glutamic Acid Decarboxylase (Gad)

Medical specialty

Immunology

Device class

2

Regulation number

866.5660

Review panel

IM

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Definition

The device is used for the semi-quantitative determination of glutamic acid decarboxylase (GAD) autoantibodies in human serum as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes).

Source

FDA openFDA device classification dataset