OMM

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

Product code

OMM

Device name

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

Device class

Class 2

21 CFR

21 CFR 864.7280

Medical specialty

Hematology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).