• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
New Search Back to Search Results
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 (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.3350
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons