Product code NPQ
- Device name
- Test, Factor V Leiden Mutations, Genomic Dna Pcr
- 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
- In vitro diagnostic test to detect the Factor V Leiden mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
- Source
- FDA openFDA device classification dataset