System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations
Medical specialty
Hematology
Device class
2
Regulation number
864.7280
Review panel
PA
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
A multiplex genotying test system intended for the qualitative detection and identification of specific thrombophilia related gene mutations from genomic DNA by genomic amplification and mass spectrometry. It is intended as an aid in diagnosis of patients with suspected thrombophilia.