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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device enzyme linked immunoabsorbent assay, cytomegalovirus
Regulation Description Cytomegalovirus serological reagents.
Product CodeLFZ
Regulation Number 866.3175
Device Class 2


Premarket Reviews
ManufacturerDecision
DIASORIN
  SUBSTANTIALLY EQUIVALENT 1
DIASORIN S.P.A
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS OPERATIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 7 7
2016 14 14
2017 13 13
2018 9 9
2019 10 10
2020 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 23 23
Incorrect, Inadequate or Imprecise Resultor Readings 13 13
High Test Results 7 7
False Negative Result 6 6
False Positive Result 6 6
Incorrect Or Inadequate Test Results 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 30 30
No Consequences Or Impact To Patient 24 24
No Patient Involvement 3 3

Recalls
Manufacturer Recall Class Date Posted
1 BioMerieux SA II Feb-14-2017
2 Diamedix Corporation II May-17-2016
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