Product code NUM

Device name

Autoantibodies, Nuclear Body Protein, Sp100

Medical specialty

Immunology

Device class

2

Regulation number

866.5090

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 SP100 (NUCLEAR BODY PROTEIN SP100) AS AN AID IN THE DIAGNOSIS OF PRIMARY BILIARY CIRRHOSIS.

Source

FDA openFDA device classification dataset