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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device kit, screening, urine
Product CodeJXA
Regulation Number 866.2660
Device Class 1

MDR Year MDR Reports MDR Events
2019 5 5
2020 15 15
2021 5 5
2022 5 5
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 19 19
Contamination /Decontamination Problem 6 6
False Negative Result 4 4
Contamination 2 2
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 18 18
No Clinical Signs, Symptoms or Conditions 10 10
No Consequences Or Impact To Patient 3 3
No Patient Involvement 1 1

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