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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzyme linked immunoabsorbent assay, varicella-zoster
Product CodeLFY
Regulation Number 866.3900
Device Class 2


Premarket Reviews
ManufacturerDecision
DIASORIN INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2 2
2022 2 2
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II Jan-04-2023
2 bioMerieux, Inc. II Feb-07-2020
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