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Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer

FDA product code NYI · 7 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.6040
Review panel
PA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2007-06-22 – 2022-09-08

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 <5.0 cm, to provide a risk assessment for distant recurrence of breast cancer. The result is indicated for use only as a prognostic marker by physicians along with a number of other factors to assess the risk of recurrence of breast cancer.

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