Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr
Medical specialty
Hematology
Device class
2
Regulation number
864.7280
Review panel
HE
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
Eligible
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.