Definition: In Vitro Diagnostic Device To Aid In The Enumeration Of Immunomagnetically Selected And Fluorescently Identified Circulating Tumor Cells Of Epithelial Origin In Whole Blood For Prediction Of Cancer Progression And Survival.
| Device Type ID | 4917 |
| Device Name | System, Immunomagnetic, Circulating Cancer Cell, Enumeration |
| Regulation Description | Immunomagnetic Circulating Cancer Cell Selection And Enumeration System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.6020 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NQI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4917 |
| Device | System, Immunomagnetic, Circulating Cancer Cell, Enumeration |
| Product Code | NQI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Immunomagnetic Circulating Cancer Cell Selection And Enumeration System. |
| CFR Regulation Number | 866.6020 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Menarini Silicon Biosystems | II | Apr-26-2018 |
| 2 | Veridex, LLC | II | Aug-18-2015 |
| 3 | Veridex, LLC | II | Mar-13-2014 |