Product code OBE

Device name

Anti-Ss-A 52 Autoantibodies

Medical specialty

Immunology

Device class

2

Regulation number

866.5100

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 detection, in human serum or plasma, of autoantibodies to SS-A 52. The detection of SS-A 52 autoantibodies may aid in the diagnosis of systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, polymyositis and dermatomyositis.

Source

FDA openFDA device classification dataset