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U.S. Department of Health and Human Services

Product Classification
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Device docetaxel / paclitaxel assay
Definition Measures levels of Docetaxel or Paclitaxel in the blood
Physical State Measures levels of Docetaxel or Paclitaxel in the blood
Technical Method Measures levels of Docetaxel or Paclitaxel in the blood
Target Area Blood
Review Panel Toxicology
Product CodePRF
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		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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