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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, rheumatoid factor
Product CodeDHR
Regulation Number 866.5775
Device Class 2


Premarket Reviews
ManufacturerDecision
KAMIYA BIOMEDICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 2 2
Output Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Suction Problem 1 1
Low Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4

Recalls
Manufacturer Recall Class Date Posted
1 The Binding Site Group, Ltd. II May-22-2020
2 The Binding Site Group, Ltd. II Mar-13-2020
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