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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lectins and protectins
Regulation Description Lectins and protectins.
Product CodeKSI
Regulation Number 864.9550
Device Class 2

MDR Year MDR Reports MDR Events
2025 700 700

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 700 700

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 700 700

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