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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
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
2019 12 12
2020 14 14
2021 11 11
2022 12 12
2023 16 16
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 29 29
High Test Results 22 22
No Apparent Adverse Event 9 9
Non Reproducible Results 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
False Negative Result 1 1
Incorrect Measurement 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 38 38
No Known Impact Or Consequence To Patient 19 19
No Consequences Or Impact To Patient 6 6
No Code Available 2 2
Missing Value Reason 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Information 1 1

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