Device |
classifier, prognostic, recurrence risk assessment, rna gene expression, breast cancer |
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 <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. |
Product Code | NYI |
Regulation Number |
866.6040
|
Device Class |
2
|
MDR Year |
MDR Reports |
MDR Events |
2023 |
1 |
1 |
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Agendia Inc |
II |
Apr-12-2010 |
|
|
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