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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device fungal organisms, nucleic acid-based assay
Definition A qualitative multiplexed in vitro diagnostic device to detect and identify fungal organisms in positive blood cultures.
Product CodePEO
Regulation Number 866.3365
Device Class 2


Premarket Reviews
ManufacturerDecision
LUMINEX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2

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