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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device fibrinogen and split products, rhodamine, antigen, antiserum, control
Regulation Description Fibrinogen determination system.
Product CodeDAR
Regulation Number 864.7340
Device Class 2

MDR Year MDR Reports MDR Events
2018 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 1 1

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