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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 Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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