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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, human growth hormone
Regulation Description Human growth hormone test system.
Product CodeCFL
Regulation Number 862.1370
Device Class 1

MDR Year MDR Reports MDR Events
2021 2 2
2022 6 6
2023 4 4
2024 5 5
2025 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 16 16
High Test Results 8 8
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Output Problem 2 2
Product Quality Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 26 26
Insufficient Information 2 2
Hormonal Imbalance 2 2

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