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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 bromcresol green dye-binding, albumin
Regulation Description Albumin test system.
Product CodeCIX
Regulation Number 862.1035
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT IRELAND DIAGNOSTICS DIVISION
  SUBSTANTIALLY EQUIVALENT 1
MEDICON HELLAS S.A
  SUBSTANTIALLY EQUIVALENT 1
TRUVIAN HEALTH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 3 3
2022 1 1
2023 4 5
2024 3 3
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 10 11
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Non Reproducible Results 5 6
High Test Results 2 2
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 17

Recalls
Manufacturer Recall Class Date Posted
1 Ortho-Clinical Diagnostics, Inc. II Aug-16-2024
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