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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device classifier, prognostic, recurrence risk assessment, rna gene expression, breast cancer
Regulation Description Gene expression profiling test system for breast cancer prognosis.
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 CodeNYI
Regulation Number 866.6040
Device Class 2


Premarket Reviews
ManufacturerDecision
AGENDIA INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2023 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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