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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device antiparietal antibody, indirect immunofluorescent, antigen, control
Regulation Description Antiparietal antibody immunological test system.
Product CodeDBJ
Regulation Number 866.5110
Device Class 2

MDR Year MDR Reports MDR Events
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hyperglycemia 1 1

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