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U.S. Department of Health and Human Services

Product Classification

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Device lamotrigine assay
Regulation Description Diphenylhydantoin test system.
Definition For the quantitative determination of lamotrigine in human serum or plasma on automated clinical chemistry analyzers.
Physical State monitoring of anti-seizure drug
Technical Method Immunoassay
Target Area in vitro diagnostic
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeORH
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.3350
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Draft Guidance for Industry and Food and Drug Administration Staff - Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm221375.htm] 
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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