Device |
illuminator system for blood products |
Definition |
Preparation and storage of pathogen-reduced, blood components. |
Physical State |
solid |
Technical Method |
chemical treatment with UVA illumination |
Target Area |
blood components |
Review Panel |
Hematology |
Product Code | PJF |
Premarket Review |
Center for Biologics Evaluation & Research (CBER)
|
Submission Type |
PMA
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|