FDA Product Code SET: Immunoassay Blood Test For Amyloid Pathology Assessment
An Immunoassay Blood Test For Amyloid Pathology Assessment Is An In Vitro Diagnostic Test Used To Identify Patients With Amyloid Pathology Associated With Alzheimers Disease Who Have Signs And Symptoms Of Cognitive Decline. The Results Of The Test Are To Be Interpreted In Conjunction With Other Patient Clinical Information.
Leading manufacturers include Fujirebio Diagnostics,Inc. and Roche Diagnostics.
List of Immunoassay Blood Test For Amyloid Pathology Assessment devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Immunoassay Blood Test For Amyloid Pathology Assessment devices (product code SET). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Immunology FDA review panel. Browse all Immunology devices →