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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device antigens, nontreponemal, all
Product CodeGMQ
Regulation Number 866.3820
Device Class 2


Premarket Reviews
ManufacturerDecision
ARLINGTON SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARLINGTON SCIENTIFIC, INC. (ASI)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 3 3
2022 14 14
2023 6 6
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 12 12
False Negative Result 6 6
False Positive Result 4 4
Device Markings/Labelling Problem 1 1
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 24 24

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