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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device photometric method, ammonia
Regulation Description Ammonia test system.
Product CodeJID
Regulation Number 862.1065
Device Class 1

MDR Year MDR Reports MDR Events
2020 26 26
2021 19 19
2022 12 12
2023 26 26
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 63 63
Low Test Results 17 17
Adverse Event Without Identified Device or Use Problem 7 7
Incorrect, Inadequate or Imprecise Result or Readings 5 5
High Readings 3 3
Low Readings 2 2
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 77 77
No Known Impact Or Consequence To Patient 9 9
No Consequences Or Impact To Patient 2 2

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