| Device Type ID | 5036 |
| Device Name | Kit, Cell Screening, Fetal |
| Review Panel | Pathology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | Contact ODE |
| FDA Device Classification | Class Not Classified Medical Device |
| Product Code | MTI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5036 |
| Device | Kit, Cell Screening, Fetal |
| Product Code | MTI |