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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device acute kidney injury test system
Definition An acute kidney injury test system is intended to measure one or more analytes in human samples as an aid in the assessment of a patient's risk for developing acute kidney injury. Test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including conifmration by alternative methods.
Product CodePIG
Regulation Number 862.1220
Device Class 2


Premarket Reviews
ManufacturerDecision
ASTUTE MEDICAL, INC
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1
ASTUTE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMÉRIEUX SA
  SUBSTANTIALLY EQUIVALENT 1
BIOPORTO DIAGNOSTIC INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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