OBEClass II
Anti-ss-a 52 Autoantibodies
Immunology · 21 CFR 866.5100
The device is used for the detection, in human serum or plasma, of autoantibodies to SS-A 52. The detection of SS-A 52 autoantibodies may aid in the diagnosis of systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, polymyositis and dermatomyositis.
MDR events0All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances3All 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
5 firms currently registered for this product code
510(k) clearances
3 clearances for this product code