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Alzheimer’S Disease Pathology Assessment Test

Alzheimer’S Disease Pathology Assessment Test is a medical device type in the Immunology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
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Alzheimer’S Disease Pathology Assessment Test
Immunology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QSE

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Class 2

21 CFR 866.5840

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Immunology

Device Characteristics

No

No

No

Not Eligible

Definition

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.

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