Product code NYI
- Device name
- Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.6040
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- A device which uses a gene expression profile of a breast cancer tumor, from patients stage i or stage ii lymph node negative, with a tumor size of
- Source
- FDA openFDA device classification dataset