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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device test, platelet antibody
Product CodeMYP
Device Class 2


Premarket Reviews
ManufacturerDecision
IMMUCOR GTI DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2017 2 2
2018 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Device Ingredient or Reagent Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4 4
No Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Death 1 1

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