Data / Medical devices / Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer (NYI): 3 FDA-registered makers in 2 countries
3 establishments in 2 countries are registered with the FDA to make Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer (product code NYI, Class 2, 21 CFR 866.6040). 2 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on September 8, 2022, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NYI
- Device class
- 2
- Regulation
- 866.6040
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| Netherlands | 1 |
Makers of Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Agendia Inc | Irvine, CA, United States | Manufacturer, Manufacturer for export | 2 | November 5, 2020 | 0 | 1 | 0 | api.fda.gov |
| Agendia NV | Amsterdam Noord-Holland, Netherlands | Specification developer | 2 | November 5, 2020 | 0 | 0 | 0 | api.fda.gov |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 8, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.