| 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 Code | ODW |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
862.3360
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
