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U.S. Department of Health and Human Services

Product Classification

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Device device,ahf,automated cryoprecipitation
Review Panel Hematology
Product CodeMYS
Premarket Review Center for Biologics Evaluation & Research (CBER)
Not Classified Reason Unknown
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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