Definition: In Vitro Diagnostic For The Detection And Genotyping Of A Single Point Mutation Of The Human 5, 10-methylenetetrahydrofolate Reductase Gene (MTHFR) In Patients With Suspected Thrombophilia.
| Device Type ID | 2434 |
| Device Name | Test 5, 10-methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr |
| Physical State | Genotyping Test System |
| Technical Method | Uses DNA Genotyping Technology To Determine Patient Genotype At The 5, 10-methylenetetrahydrofolate Reductase Gene Locus. |
| Target Area | Clinical Samples (blood, Saliva, Buccal Swab Samples) |
| Regulation Description | Factor V Leiden DNA Mutation Detection Systems. |
| 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 | 864.7280 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OMM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |