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

FDA product code OMM · 2 cleared devices

Class 2 Hematology
Regulation
21 CFR 864.7280
Review panel
HE
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2011-04-25 – 2011-05-13

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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