OMM · Class II · 21 CFR 864.7280

FDA Product Code OMM: Test 5, 10-methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr

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.

2
Total
2
Cleared
413d
Avg days
2011
Since

FDA 510(k) Cleared Test 5, 10-methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr Devices (Product Code OMM)

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About Product Code OMM - Regulatory Context