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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device kit, screening, staphylococcus aureus
Product CodeJWX
Regulation Number 866.2660
Device Class 1


Premarket Reviews
ManufacturerDecision
BINAX, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 4 4
2016 3 3
2020 1 1
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 6 6
False Negative Result 2 2
Off-Label Use 1 1
Incorrect Or Inadequate Test Results 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4 4
No Clinical Signs, Symptoms or Conditions 2 2
No Consequences Or Impact To Patient 2 2
No Patient Involvement 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II Jan-04-2023
2 NERL Diagnostics Corporation II Mar-12-2010
3 Remel, Inc II Feb-23-2010
4 Remel, Inc III Mar-20-2009
5 bioMerieux, Inc. II Feb-16-2012
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