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U.S. Department of Health and Human Services

Product Classification
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Device minoxidil sulfotransferase or isoenzymes test system
Definition For measurement of Minoxidil sulfotransferase as an aid in assessing the likelihood that a patient will respond to minoxidil.
Physical State Liquid
Technical Method Colorimetric in vitro diagnostic assay performed by a medical professional
Target Area Laboratory test
Review Panel Toxicology
Product CodePSS
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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