| Device Type ID | 2483 |
| Device Name | Vials, Challenge, Endotoxin |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | Contact ODE |
| FDA Device Classification | Class Not Classified Medical Device |
| Product Code | MTS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2483 |
| Device | Vials, Challenge, Endotoxin |
| Product Code | MTS |