NJF

Antibodies, Anti-Actin, Anti-Smooth Muscle

Product code

NJF

Device name

Antibodies, Anti-Actin, Anti-Smooth Muscle

Device class

Class 2

21 CFR

21 CFR 866.5120

Medical specialty

Immunology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).