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U.S. Department of Health and Human Services

Product Classification

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Device gabapentin assay
Regulation Description Diphenylhydantoin test system.
Definition Test for the quantitative determination of gabapentin in human serum or plasma. Gabapentin concentrations can be used as an aid in management of patients treated with gabapentin.
Physical State Liquid reagents
Technical Method Quantitative, Homogenous Enzyme Immunoassay
Target Area in vitro diagnostic
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeOTF
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