| Device Type ID | 5038 |
| Device Name | System, Test, Her-2/neu, Nucleic Acid Or Serum |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MVD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5038 |
| Device | System, Test, Her-2/neu, Nucleic Acid Or Serum |
| Product Code | MVD |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Device Damaged Prior To Use | 1 |
| Total Device Problems | 1 |