Device typeInherited thrombophilia IVD, kit, nucleic acid technique (NAT): A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict inherited thrombophilia, which may be associated with, but not limited to, the prothrombin 20,210 mutation and/or the Factor V Leiden mutation (activated protein C resistance), using a nucleic acid technique (NAT).
FDA categoryTest, Factor Ii G20210a Mutations, Genomic Dna Pcr, Test, Factor V Leiden Mutations, Genomic Dna Pcr
Device ID07332940000240
Catalog numberGXFIIFV-10
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information