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U.S. Department of Health and Human Services

Product Classification

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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 CodePJF
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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