OMMClass II
Test 5, 10-methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr
Hematology · 21 CFR 864.7280
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.
MDR events1All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances2All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Malfunction1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
2 clearances for this product code