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U.S. Department of Health and Human Services

Product Classification
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Device system, test, automated blood grouping and antibody
Regulation Description Automated blood grouping and antibody test system.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeKSZ
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
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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