Vitamin K Epoxide Reductase Complex Subunit One (vkorc1) Genotyping System
Device Code: 2433
Product Code(s):
ODV 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.
Device Classification Information
| Device Type ID | 2433 |
| Device Name | Vitamin K Epoxide Reductase Complex Subunit One (vkorc1) Genotyping System |
| 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 Description | Prothrombin Time Test. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 864.7750 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ODV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 2433 |
| Device | Vitamin K Epoxide Reductase Complex Subunit One (vkorc1) Genotyping System |
| Product Code | ODV |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Prothrombin Time Test. |
| CFR Regulation Number | 864.7750 [🔎] |
TPLC Last Update: 2019-04-02 20:11:57