OIFClass II
Tyrosine Phosphatase (ia-2) Autoantibody Assay
Immunology · 21 CFR 866.5660
The device is used for the semi-quantitative determination of autoantibodies against tyrosine phosphatase (IA-2) in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes).
MDR events0All time
Recalls0All time
Registered firms6Currently 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
6 firms currently registered for this product code
510(k) clearances
3 clearances for this product code