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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dna probe, trichomonas vaginalis
Regulation Description Microorganism differentiation and identification device.
Product CodeMJK
Regulation Number 866.2660
Device Class 1

MDR Year MDR Reports MDR Events
2022 1 1
2023 6 6
2024 3 3
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Failure of Device to Self-Test 5 5
Unable to Obtain Readings 3 3
Use of Device Problem 3 3
High impedance 1 1
Failure to Power Up 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12
Burn(s) 1 1

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