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U.S. Department of Health and Human Services

Product Classification
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Device test, qualitative, for hla, non-diagnostic
Review Panel Hematology
Product CodeMZI
Premarket Review Center for Biologics Evaluation & Research (CBER)
Unclassified Reason Pre-Amendment
Submission Type 510(k)
Device Class Unclassified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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