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U.S. Department of Health and Human Services

Product Classification

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Device cytochrome p450 2c9 (cyp450 2c9) drug metabolizing enzyme genotyping system
Regulation Description Drug metabolizing enzyme genotyping system.
Definition An in vitro diagnostic assay for use in genotyping Cytochrome P450 2C9 (CYP450 2C9) alleles. Information about the CYP2C9 genotype may be used as an aid to clinicians in determining therapeutic strategy for medications that are metabolized by the CYP2C9 gene product.
Physical State genotyping test system
Technical Method Uses DNA genotyping technology to determine patient genotype at the Cytochrome P450 2C9 (CYP450 2C9) locus.
Target Area clinical samples (blood, saliva, buccal swab samples)
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeODW
Premarket Review Division of Chemistry and Toxicology Devices (DCTD)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.3360
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons