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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 autoantibodies, endomysial(tissue transglutaminase)
Regulation Description Multiple autoantibodies immunological test system.
Product CodeMVM
Regulation Number 866.5660
Device Class 2


Premarket Reviews
ManufacturerDecision
EUROIMMUN US, INC.
  SUBSTANTIALLY EQUIVALENT 1
INOVA DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHADIA AB
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
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 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bio-Rad Labs II Apr-24-2020
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