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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 radioimmunoassay, acth
Product CodeCKG
Regulation Number 862.1025
Device Class 2


Premarket Reviews
ManufacturerDecision
IMMUNODIAGNOSTIC SYSTEMS LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 8 8
2020 1 1
2022 1 1
2023 3 3
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 11 11
Non Reproducible Results 4 4
Low Test Results 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
No Code Available 6 6
No Consequences Or Impact To Patient 3 3

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