Definition: Preparation And Storage Of Pathogen-reduced, Blood Components.
| Device Type ID | 2508 |
| Device Name | Illuminator System For Blood Products |
| Physical State | Solid |
| Technical Method | Chemical Treatment With UVA Illumination |
| Target Area | Blood Components |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PJF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2508 |
| Device | Illuminator System For Blood Products |
| Product Code | PJF |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Appropriate Term/Code Not Available | 4 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Microbial Contamination Of Device | 1 |
| Total Device Problems | 6 |