NUM

Autoantibodies, Nuclear Body Protein, Sp100

Product code

NUM

Device name

Autoantibodies, Nuclear Body Protein, Sp100

Device class

Class 2

21 CFR

21 CFR 866.5090

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 DETECTION, IN HUMAN SERUM OR PLASMA, OF AUTOANTIBODIES TO SP100 (NUCLEAR BODY PROTEIN SP100) AS AN AID IN THE DIAGNOSIS OF PRIMARY BILIARY CIRRHOSIS.

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