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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
Definition Cber.
Review Panel Hematology
Product CodeMZI
Unclassified Reason Pre-Amendment
Submission Type 510(k)
Device Class Unclassified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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