Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr
The Test for 5,10-Methylenetetrahydrofolate Reductase (MTHFR) Mutations, Genomic DNA PCR (product code OMM) is a Class 2 in vitro diagnostic device regulated under 21 CFR 864.7280 in the Hematology specialty (HE), cleared via 510(k). It is intended for the detection and genotyping of a single point mutation in the human MTHFR gene in patients with suspected thrombophilia, using polymerase chain reaction methodology. The device is eligible for third-party review and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- OMM
- Device Class
- FDA class 2
- Regulation Number
- 864.7280
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.