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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device parathyroid autofluorescence detection device
Regulation Description Autofluorescence detection device for general surgery and dermatological use.
Definition An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.
Product CodeQDF
Regulation Number 878.4550
Device Class 2

MDR Year MDR Reports MDR Events
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 3 3
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3

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