OMM — Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr Class II
FDA product code OMM covers "Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr", a Class II medical device regulated under 21 CFR 864.7280. Submissions are reviewed by the Hematology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OMM
- Device Class
- Class II
- Regulation Number
- 864.7280
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
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.