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U.S. Department of Health and Human Services

Product Classification

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Device levetiracetam assay
Regulation Description Diphenylhydantoin test system.
Definition For the quantitative determination of levetiracetam in human serum or plasma.
Physical State measurement of anit-seizure medication
Technical Method immunoassay
Target Area in vitro diagnostic
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeORI
Premarket Review Division of Chemistry and Toxicology Devices (DCTD)
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