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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device autoantibodies, endomysial(tissue transglutaminase)
Product CodeMVM
Regulation Number 866.5660
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-RAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
EUROIMMUN US, INC.
  SUBSTANTIALLY EQUIVALENT 1
GRIFOLS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMMCO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
INOVA DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
PHADIA AB
  SUBSTANTIALLY EQUIVALENT 1
SQI DIAGNOSTICS SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SQI DIAGNOSTICS SYSTEMS INC.
  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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