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U.S. Department of Health and Human Services

Product Classification

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Device platelets, photochemical treatment system
Definition The photochemical treatment system is a class iii medical device for the preparation and storage of pathogen reduced donor derived platelets.The device has the process capability for the pathogen inactivation of platelets having platelet counts of 2.5-6.0x1011.The platelet products are indicated for support of patients requiring platelet transfusion according to clinical practice guidelines.There is no intended pharmacological effect attributed to residual amotosalen (s-59) in the platelet product.
Review Panel Hematology
Product CodeNJN
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type Contact ODE
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