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U.S. Department of Health and Human Services

Product Classification
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Device 5-fluorouracil assay
Definition Measures levels of a chemotherapy drug in the blood.
Physical State Measures levels of a chemotherapy drug in the blood
Technical Method Measures levels of a chemotherapy drug in the blood
Target Area the blood
Review Panel Toxicology
Product CodeOXR
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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