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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, epithelial ovarian tumor-associated antigen (ca125)
Product CodeLTK
Regulation Number 866.6010
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC
  SUBSTANTIALLY EQUIVALENT 1
ORTHO CLINICAL DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 5 5
2021 2 2
2022 2 2
2023 6 6
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 11 11
High Test Results 9 9
No Apparent Adverse Event 3 3
Non Reproducible Results 2 2
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16
No Known Impact Or Consequence To Patient 5 5

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