QSEClass II
Alzheimers Disease Pathology Assessment Test
Immunology · 21 CFR 866.5840
In vitro test to determine whether a patient presenting with cognitive impairment and being evaluated for AD and other causes of cognitive decline will test positive or negative for amyloid plaques or neurofibrillary tangles as measured by PET imaging agents.
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