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Immunoassay Blood Test For Amyloid Pathology Assessment

FDA product code SET · 4 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.5840
Review panel
IM
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2025-05-16 – 2026-08-19

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.

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