Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Alzheimer’S Disease Pathology Assessment Test

FDA product code QSE · 2 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
2022-12-07 – 2023-06-05

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.

↑