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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device immunoassay, anti-seizure drug
Regulation Description Diphenylhydantoin test system.
Definition To aid in management of patients treated with anti-seizure drug.
Product CodeNWM
Regulation Number 862.3350
Device Class 2


Premarket Reviews
ManufacturerDecision
ARK DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2

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