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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
SIEMENS HEALTHCARE DISGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 14 14
2021 11 11
2022 12 12
2023 16 16
2024 15 15
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 32 32
Low Test Results 28 28
Non Reproducible Results 10 10
Incorrect, Inadequate or Imprecise Result or Readings 4 4
No Apparent Adverse Event 4 4
Incorrect Measurement 2 2
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 56 56
No Known Impact Or Consequence To Patient 11 11
No Consequences Or Impact To Patient 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Information 1 1

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