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U.S. Department of Health and Human Services

Product Classification

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Device test, equipment, automated bloodborne pathogen
Review Panel Immunology
Product CodeMZA
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
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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