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U.S. Department of Health and Human Services

Product Classification

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Device software, blood bank, stand alone products
Regulation Description Automated blood grouping and antibody test system.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeMMH
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type 510(k)
Regulation Number 864.9175
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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