| Device |
vitamin k epoxide reductase complex subunit one (vkorc1) genotyping system |
| Regulation Description |
Prothrombin time test. |
| Definition |
An in vitro diagnostic assay for use in genotyping vitamin k epoxide reductase complex subunit one (vkorc1) alleles to aid in the identification of patients at risk for altered warfarin sensitivity. |
| Physical State |
genotyping test system |
| Technical Method |
Uses DNA genotyping technology to determine patient genotype at the Vitamin k epoxide reductase complex subunit one (VKORC1) gene locus. |
| Target Area |
clinical samples (blood, saliva, buccal swab samples) |
| Regulation Medical Specialty |
Hematology |
| Review Panel |
Hematology |
|---|
| Product Code | ODV |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
864.7750
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
