Product code NJF

Device name

Antibodies, Anti-Actin, Anti-Smooth Muscle

Medical specialty

Immunology

Device class

2

Regulation number

866.5120

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 detection of IgG antibodies to the actin component of smooth muscle in human serum as an aid in the diagnosis of certain autoimmune liver diseases, e.g. autoimmune hepatitis.

Source

FDA openFDA device classification dataset