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U.S. Department of Health and Human Services

Product Classification

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Device blood establishment computer software, user developed
Definition To store information that blood establishement personnel use to make decisions concerning the suitability of blood and blood products for further manufacture or transfusion.
Physical State solid
Technical Method Software
Target Area blood establishment
Review Panel Hematology
Product CodeOYT
Premarket Review Center for Biologics Evaluation & Research (CBER)
Unclassified Reason Pre-Amendment
Submission Type 510(K) Exempt
Device Class Unclassified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible