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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 enzymatic method, creatinine
Regulation Description Creatinine test system.
Product CodeJFY
Regulation Number 862.1225
Device Class 2


Premarket Reviews
ManufacturerDecision
HORIBA ABX SAS
  SUBSTANTIALLY EQUIVALENT 1
QSTAG, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 57 57
2022 9 9
2023 36 36
2024 34 34
2025 60 60
2026 37 37

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 93 93
Low Test Results 57 57
Non Reproducible Results 47 47
Incorrect, Inadequate or Imprecise Result or Readings 20 20
No Apparent Adverse Event 20 20
Output Problem 6 6
Insufficient Device Problem Information 6 6
Appropriate Device Problem Term/Code Not Available 6 6
Incorrect Measurement 4 4
Chemical Problem 1 1
Compatibility Problem 1 1
Imprecision 1 1
Unable to Obtain Readings 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 223 223
Insufficient Information 7 7
No Consequences Or Impact To Patient 3 3
Unspecified Kidney or Urinary Problem 1 1

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