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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device system, test, vitamin d
Regulation Description Vitamin D test system.
Product CodeMRG
Regulation Number 862.1825
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER INC
  SUBSTANTIALLY EQUIVALENT 1
IMMUNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 10 10
2021 15 15
2022 13 13
2023 22 22
2024 35 35
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 70 70
Non Reproducible Results 54 54
Low Test Results 18 18
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Low Readings 5 5
Incorrect Measurement 5 5
High Readings 4 4
Material Integrity Problem 3 3
Insufficient Information 2 2
Chemical Problem 2 2
Failure to Calibrate 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Degraded 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 81 81
No Consequences Or Impact To Patient 14 14
Insufficient Information 1 1

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