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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State liquid reagents
Technical Method Immunoassay intented for use on clinical chemistry analyzers
Target Area in vitro diagnostic
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeNWM
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