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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cyclosporine
Regulation Description Cyclosporine test system.
Product CodeMKW
Regulation Number 862.1235
Device Class 2

MDR Year MDR Reports MDR Events
2020 2 2
2021 6 6
2022 7 7
2023 5 5
2024 6 6
2025 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 20 20
High Test Results 12 12
Incorrect, Inadequate or Imprecise Result or Readings 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 30 30
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 1 1
Convulsion/Seizure 1 1

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