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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device coverslips, microscope slide
Product CodeKES
Regulation Number 864.3010
Device Class 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 1 1
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Discolored 1 1
Device Difficult to Setup or Prepare 1 1
Product Quality Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
Tissue Damage 1 1
Test Result 1 1
Unspecified Tissue Injury 1 1

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