Product code OIF

Device name

Tyrosine Phosphatase (Ia-2) Autoantibody Assay

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 autoantibodies against tyrosine phosphatase (IA-2) in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes).

Source

FDA openFDA device classification dataset