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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 system, test, carcinoembryonic antigen
Regulation Description Tumor-associated antigen immunological test system.
Product CodeDHX
Regulation Number 866.6010
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO CLINICAL DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 11 11
2022 12 13
2023 15 15
2024 15 15
2025 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 39 39
Low Test Results 22 23
Non Reproducible Results 16 16
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Low Readings 3 3
Incorrect Measurement 2 2
Mechanical Problem 1 1
Pumping Problem 1 1
High Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 69 70
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Information 1 1
No Consequences Or Impact To Patient 1 1

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