Device |
alzheimer’s disease pathology assessment test |
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. |
Product Code | QSE |
Regulation Number |
866.5840
|
Device Class |
2
|
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