OCB · Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection
· Class 3
Overview
| Product Code | OCB |
|---|---|
| Device Name | Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection |
| Device Class | Class 3 |
| Review Panel | |
| Life-Sustaining | Yes |
Identification
A gene expression test for detection of cancer metastasisis an in vitro diagnostic test performed on tissue of interest from patients previously diagnosed with cancer. Results from the test can be used to guide the intra-operative or post-operative decision to remove additional tissue. Post-operative histological evaluation of permanent sections of the tissue specimen, in accordance with usual diagnostic practice and using an appropriate histological sampling scheme, is required.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P060017 | GENESEARCH BREAST LYMPH NODE(BLN) ASSAY | Janssen Diagnostics | Jul 16, 2007 | APWD |
Top Applicants
- Janssen Diagnostics — 1 clearance
