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U.S. Department of Health and Human Services

Product Classification

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Device kit,western blot,hiv-1
Review Panel Hematology
Product CodeMVW
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible