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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
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
2019 15 15
2020 5 5
2021 2 2
2022 2 2
2023 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 16 16
Low Test Results 10 10
No Apparent Adverse Event 5 5
Non Reproducible Results 2 2
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 19 19
No Clinical Signs, Symptoms or Conditions 10 10
No Consequences Or Impact To Patient 1 1

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