OMM

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr

Device class

Class II (moderate risk)

Regulation

21 CFR 864.7280

Medical specialty

Hematology

Flags

Third-party review eligible

FDA 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.

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