Home › Device types › NYI
Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
FDA product code NYI · Class 2 · Immunology
6
Registered devices
1
Adverse events
1
Recalls
10
510(k) clearances
Devices with this code
Prosigna Breast Cancer Prognostic Gene Signature Assay — NANOSTRING TECHNOLOGIES, INC.Prosigna Breast Cancer Prognostic Gene Signature Assay — NANOSTRING TECHNOLOGIES, INC.Prosigna Breast Cancer Prognostic Gene Signature Assay — NANOSTRING TECHNOLOGIES, INC.Prosigna Breast Cancer Prognostic Gene Signature Assay — NANOSTRING TECHNOLOGIES, INC.Prosigna Breast Cancer Prognostic Gene Signature Assay — NANOSTRING TECHNOLOGIES, INC.MammaPrint FFPE — Agendia, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-03-03 | Agendia Inc | Over a period of about 6 months in about 15% of results provided Agendia has been "over reporting" the chance of metastasis risk being 29% risk of recurrence in |
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