Device type

Immunoassay Blood Test For Amyloid Pathology Assessment

Product code SET · Class II · 21 CFR 866.5840 · Immunology

An Immunoassay blood test for amyloid pathology assessment is an in vitro diagnostic test used to identify patients with amyloid pathology associated with Alzheimer’s 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.

FDA classification database