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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device test, cystatin c
Regulation Description Creatinine test system.
Product CodeNDY
Regulation Number 862.1225
Device Class 2


Premarket Reviews
ManufacturerDecision
SENTINEL CH. S.P.A.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 2 2
2024 3 3
2025 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 10 10
High Test Results 4 4
Non Reproducible Results 2 2
Low Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14 14

Recalls
Manufacturer Recall Class Date Posted
1 Gentian AS II Oct-13-2020
2 Randox Laboratories Ltd. II Jul-24-2024
3 Randox Laboratories Ltd. II Mar-22-2024
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