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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzymatic method, ammonia
Product CodeJIF
Regulation Number 862.1065
Device Class 1


Premarket Reviews
ManufacturerDecision
ROCHE DIAGNOSTICS OPERATIONS (RDO)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2021 1 1
2022 2 2
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 8 8
Non Reproducible Results 4 4
Incorrect, Inadequate or Imprecise Result or Readings 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
No Consequences Or Impact To Patient 2 2
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 RANDOX LABORATORIES, LTD. II Sep-14-2020
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