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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 CodeQSE
Regulation Number 866.5840
Device Class 2


Premarket Reviews
ManufacturerDecision
FUJIREBIO DIAGNOSTICS, INC.
  GRANTED 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2

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