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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device immunoassay blood test for amyloid pathology assessment
Definition 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.
Product CodeSET
Regulation Number 866.5840
Device Class 2


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

Recalls
Manufacturer Recall Class Date Posted
1 Fujirebio Diagnostics, Inc. II Feb-05-2026
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