Product Classification

• 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