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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
Regulation Description Varicella-zoster virus serological reagents.
Product CodeLFY
Regulation Number 866.3900
Device Class 2


Premarket Reviews
ManufacturerDecision
DIASORIN
  SUBSTANTIALLY EQUIVALENT 1
  1.  K150375  LIAISON VZV IgG, LIAISON Control VZV IgG
DIASORIN S.P.A
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 20 20
2016 2 2
2018 2 2
2019 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 20 20
Incorrect, Inadequate or Imprecise Resultor Readings 5 5
Incorrect Or Inadequate Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 22 22
No Consequences Or Impact To Patient 3 3
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 bioMerieux, Inc. II Feb-07-2020
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