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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 purple dye-binding, albumin
Regulation Description Albumin test system.
Product CodeCJW
Regulation Number 862.1035
Device Class 2


Premarket Reviews
ManufacturerDecision
SENTINEL CH. SPA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1 1
2019 3 4
2021 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 8 9
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
No Consequences Or Impact To Patient 2 2
No Known Impact Or Consequence To Patient 2 3

Recalls
Manufacturer Recall Class Date Posted
1 Roche Diagnostics Corporation II Apr-18-2019
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