NRIClass II
Autoantibodies, Nuclear Pore Glycoprotein Gp210
Immunology · 21 CFR 866.5090
The device is used for the detection, in human serum or plasma, of autoantibodies to gp210 (nuclear pore glycoprotein gp210) as an aid in the diagnosis of primary biliary cirrhosis.
MDR events0All time
Recalls0All time
Registered firms7Currently listed
510(k) clearances2All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
7 firms currently registered for this product code
510(k) clearances
2 clearances for this product code