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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, leukocyte peroxidase
Product CodeGIA
Regulation Number 864.7675
Device Class 1

MDR Year MDR Reports MDR Events
2017 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 1 1
Mechanical Jam 1 1
Mechanics Altered 1 1

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

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