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U.S. Department of Health and Human Services

Product Classification

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Device test, methadone, over the counter
Regulation Description Methadone test system.
Definition The methadone test is an in vitro diagnostic test for the qualitative analysis of methadone in human urine.
Physical State In vitro diagnostic device
Technical Method Immunoassay
Target Area Urine
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodePTG
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.3620
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
Accredited Persons
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