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U.S. Department of Health and Human Services

Product Classification
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Device infliximab test system
Definition An infliximab test system intended for the measurement of an infliximab as an aid in the management of patients with Crohn’s disease or ulcerative colitis.
Physical State Solid, dried reagent pack
Technical Method Immunoassay
Target Area Serum
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeQXT
Premarket Review Division of Chemistry and Toxicology Devices (DCTD)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.3115
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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